FDA Product Code
FDA Product Code DXN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1130
510(k) Clearances — 1,226 records · page 1 of 13
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260470 | Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) | Shenzhen Brav Electronic Technologies Co., Ltd. | 2026-10-01 | Traditional | PDF ↗ |
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | 2026-09-10 | Special | PDF ↗ |
| K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026-09-03 | Traditional | PDF ↗ |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | 2026-08-31 | Special | PDF ↗ |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | 2026-08-26 | Traditional | PDF ↗ |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | 2026-08-13 | Traditional | PDF ↗ |
| K261061 | BP Go (BPP-855) | Wellvii, Inc. | 2026-08-13 | Traditional | PDF ↗ |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 | Traditional | PDF ↗ |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | 2026-07-23 | Traditional | PDF ↗ |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | 2026-06-16 | Traditional | PDF ↗ |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | 2026-06-15 | Traditional | PDF ↗ |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 | Traditional | PDF ↗ |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 | Traditional | PDF ↗ |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 | Traditional | PDF ↗ |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026-05-06 | Traditional | PDF ↗ |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | 2026-04-28 | Special | PDF ↗ |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | 2026-04-28 | Traditional | PDF ↗ |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 | Traditional | PDF ↗ |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 | Traditional | PDF ↗ |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 | Special | PDF ↗ |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 | Traditional | PDF ↗ |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 | Traditional | PDF ↗ |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 | Traditional | PDF ↗ |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-01-12 | Traditional | PDF ↗ |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | 2026-01-09 | Special | PDF ↗ |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | 2025-10-27 | Traditional | PDF ↗ |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. | 2025-10-09 | Special | PDF ↗ |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. | 2025-10-02 | Special | PDF ↗ |
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan E-Test Technology Co., Ltd. | 2025-09-03 | Traditional | PDF ↗ |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corporation | 2025-08-06 | Traditional | PDF ↗ |
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co, Ltd. | 2025-08-04 | Abbreviated | PDF ↗ |
| K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | 2025-07-30 | Traditional | PDF ↗ |
| K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025-07-16 | Traditional | PDF ↗ |
| K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd. | 2025-07-14 | Traditional | PDF ↗ |
| K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025-07-02 | Traditional | PDF ↗ |
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co. , Ltd. | 2025-06-26 | Traditional | PDF ↗ |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-05-02 | Traditional | PDF ↗ |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-30 | Traditional | PDF ↗ |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-24 | Traditional | PDF ↗ |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. | 2025-04-08 | Special | PDF ↗ |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | 2025-03-14 | Special | PDF ↗ |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. | 2025-02-21 | Traditional | PDF ↗ |
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 | Traditional | PDF ↗ |
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-11 | Traditional | PDF ↗ |
| K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | 2025-02-07 | Special | PDF ↗ |
| K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | 2025-02-05 | Traditional | PDF ↗ |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-03 | Traditional | PDF ↗ |
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | 2025-01-30 | Traditional | PDF ↗ |
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Murata Vios, Inc. | 2025-01-23 | Traditional | PDF ↗ |
| K241066 | BB-613-BPM | Biobeat Technologies , Ltd. | 2025-01-14 | Traditional | PDF ↗ |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co. , Ltd. | 2025-01-13 | Traditional | PDF ↗ |
| K242528 | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) | Shenzhen Ruiankang Technology Co., Ltd. | 2025-01-10 | Traditional | PDF ↗ |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-11-26 | Traditional | PDF ↗ |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Shenzhen Urion Technology Co., Ltd. | 2024-10-24 | Traditional | PDF ↗ |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Avita Corporation | 2024-10-22 | Traditional | PDF ↗ |
| K241613 | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | Shenzhen Hbcare Technology Co.,Ltd | 2024-10-16 | Traditional | PDF ↗ |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | Shenzhen Finicare Co., Ltd. | 2024-10-04 | Special | PDF ↗ |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-08-21 | Special | PDF ↗ |
| K241129 | Upper Arm Electronic Blood Pressure Monitor | Shenzhen Goodlymed Technology Co., Ltd. | 2024-07-03 | Traditional | PDF ↗ |
| K240729 | Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) | Shenzhen Pango Medical Electronics Co., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-06-07 | Traditional | PDF ↗ |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-05-31 | Traditional | PDF ↗ |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-04-29 | Traditional | PDF ↗ |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) | Andon Health Co, Ltd. | 2024-04-22 | Abbreviated | PDF ↗ |
| K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2024-03-26 | Traditional | PDF ↗ |
| K233146 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | 2024-03-19 | Traditional | PDF ↗ |
| K233799 | Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | Shenzhen Yuezhongxing Technology Co., Ltd. | 2024-03-15 | Traditional | PDF ↗ |
| K231303 | Arm-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | 2024-01-26 | Traditional | PDF ↗ |
| K230996 | Pursuant Health Kiosk (G1.D5) | Pursuant Health | 2024-01-04 | Traditional | PDF ↗ |
| K233130 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K231478 | Digital Blood Pressure Monitor (Model: YB-800) | Wenzhou Yosun Medical Technology Co.,Ltd | 2023-12-15 | Traditional | PDF ↗ |
| K232815 | Wrist Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023-12-11 | Traditional | PDF ↗ |
| K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023-12-08 | Traditional | PDF ↗ |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | 2023-12-05 | Traditional | PDF ↗ |
| K232814 | Electronic Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023-12-05 | Traditional | PDF ↗ |
| K231250 | Digital Blood Pressure Monitor | Guangdong Genial Technology Co., Ltd. | 2023-11-28 | Traditional | PDF ↗ |
| K232713 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-28 | Traditional | PDF ↗ |
| K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-22 | Traditional | PDF ↗ |
| K231245 | Digital Blood Pressure Monitor (Arm Type) | Guangdong Genial Technology Co., Ltd. | 2023-11-22 | Traditional | PDF ↗ |
| K231310 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | 2023-10-27 | Traditional | PDF ↗ |
| K230919 | Acumen IQ finger cuff | Edwards Lifesciences, LLC | 2023-10-24 | Traditional | PDF ↗ |
| K231050 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2023-10-11 | Traditional | PDF ↗ |
| K223873 | Boppli Infant Blood Pressure Monitor | Pyrames, Inc. | 2023-09-29 | Traditional | PDF ↗ |
| K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Shenzhen Finicare Co., Ltd. | 2023-09-18 | Traditional | PDF ↗ |
| K230649 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2023-09-07 | Traditional | PDF ↗ |
| K231542 | Digital Blood Pressure Monitor WBP Series | Weony (Shenzhen) Technology Co., Ltd. | 2023-09-07 | Traditional | PDF ↗ |
| K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L) | Shenzhen Jamr Technology Co., Ltd. | 2023-08-25 | Traditional | PDF ↗ |
| K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | 2023-08-25 | Traditional | PDF ↗ |
| K230642 | Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd. | 2023-08-11 | Traditional | PDF ↗ |
| K231174 | BPBIO750 | Inbody Co., Ltd. | 2023-08-02 | Traditional | PDF ↗ |
| K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-07-26 | Traditional | PDF ↗ |
| K223374 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-06-30 | Traditional | PDF ↗ |
| K230176 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | 2023-06-29 | Traditional | PDF ↗ |
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Microlife Intellectual Property GmbH | 2023-06-28 | Traditional | PDF ↗ |
| K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023-06-21 | Traditional | PDF ↗ |
Product code DXN · Class II · Cardiovascular. Data: openFDA.