FDA Product Code
FDA Product Code DXQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1120
510(k) Clearances — 199 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026-06-22 | Traditional | PDF ↗ |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | 2026-05-06 | Traditional | PDF ↗ |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | 2026-01-09 | Special | PDF ↗ |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | 2025-12-16 | Traditional | PDF ↗ |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | 2025-09-03 | Traditional | PDF ↗ |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. | 2025-07-15 | Traditional | PDF ↗ |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | 2024-10-31 | Traditional | PDF ↗ |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | 2024-03-20 | Traditional | PDF ↗ |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) | Shenzhen Plinma Technology Co. , Ltd. | 2023-11-29 | Traditional | PDF ↗ |
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-30 | Traditional | PDF ↗ |
| K230859 | Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd | 2023-06-28 | Traditional | PDF ↗ |
| K230145 | ONE-CUF | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 | Traditional | PDF ↗ |
| K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | Cardicare Company, Ltd. | 2022-11-28 | Traditional | PDF ↗ |
| K222420 | Disposable Blood Pressure Cuff | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K221857 | Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 | Zhejiang Lude Technology Development Co., Ltd. | 2022-10-13 | Traditional | PDF ↗ |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 | Wenzhou Xikang Medical Instruments Co., Ltd. | 2022-05-18 | Traditional | PDF ↗ |
| K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. | 2021-10-19 | Traditional | PDF ↗ |
| K211747 | Reusable NIBP Cuff | Shenzhen Coreray Technology Co., Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K203620 | Aneroid Sphygmomanometer | Wuxi Exanovo Medical Instrument Co., Ltd. | 2021-03-23 | Traditional | PDF ↗ |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D | Jkh USA, LLC | 2021-01-06 | Traditional | PDF ↗ |
| K193259 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Little Doctor Electronic (Nantong)Co.,Ltd | 2020-07-02 | Traditional | PDF ↗ |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Honsun (Nantong) Co., Ltd. | 2020-04-06 | Traditional | PDF ↗ |
| K193629 | Disposable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-25 | Traditional | PDF ↗ |
| K191253 | Reusable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-09-17 | Traditional | PDF ↗ |
| K191209 | Aneroid Type Blood Pressure Kit | Dongguan Mars Medical Products Co., Ltd. | 2019-06-18 | Traditional | PDF ↗ |
| K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope | Wenzhou Renhua Instruments Co., Ltd. | 2019-05-22 | Traditional | PDF ↗ |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-17 | Traditional | PDF ↗ |
| K173197 | Reusable NIBP Cuff | Orantech, Inc. | 2018-08-21 | Traditional | PDF ↗ |
| K173869 | Med-link Reusable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2018-08-02 | Traditional | PDF ↗ |
| K173246 | ANEROID SPHYGMOMANOMETER | Wenzhou Bokang Instruments Co., Ltd. | 2018-05-30 | Abbreviated | PDF ↗ |
| K180335 | Accutension Smartphone Auscultatory Blood | Shanghai Hulu Devices Co., Ltd. | 2018-03-08 | Traditional | PDF ↗ |
| K171889 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017-12-19 | Traditional | PDF ↗ |
| K173044 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Ningbo Albert Novosino Co., Ltd. | 2017-11-20 | Traditional | PDF ↗ |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2016-11-28 | Traditional | PDF ↗ |
| K161035 | Medline Singe Patient Use Blood Pressure Cuff | Medline Industries, Inc. | 2016-06-13 | Traditional | PDF ↗ |
| K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | 2016-05-05 | Traditional | PDF ↗ |
| K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff | Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. | 2016-04-14 | Traditional | PDF ↗ |
| K151810 | Bpump Blood Pressure Cuff | Shenzhen Pump Medical System Co., Ltd. | 2015-12-17 | Traditional | PDF ↗ |
| K152468 | Reusable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 | Traditional | PDF ↗ |
| K152465 | Disposable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 | Traditional | PDF ↗ |
| K152801 | ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT | Statcorp Medical | 2015-10-27 | Special | PDF ↗ |
| K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M | Philips Medical Systems | 2015-10-27 | Special | PDF ↗ |
| K151246 | Aneroid Sphygmomanometer | Jiaxing Zhongfa Medical Products Co., Ltd. | 2015-06-30 | Traditional | PDF ↗ |
| K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | 2015-06-30 | Traditional | PDF ↗ |
| K143728 | Minhua Disposable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus | 2015-05-15 | Traditional | PDF ↗ |
| K143332 | Fast Sphyg by Koven | Koven Technology, Inc. | 2015-04-14 | Traditional | PDF ↗ |
| K150227 | Disposable Blood Pressure Cuff Guard | Pinhu Sama Medical Packing Co., Ltd. | 2015-04-02 | Traditional | PDF ↗ |
| K141998 | SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS | Pinghu Sama Medical Packing Co., Ltd. | 2014-09-19 | Traditional | PDF ↗ |
| K140874 | GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF | Shanghai Goahui Rubber and Plastic Company | 2014-09-02 | Traditional | PDF ↗ |
| K141392 | SPHYGMOMANOMETER | Suzhou JJ Meter Co., Ltd. | 2014-07-02 | Traditional | PDF ↗ |
| K133117 | ANDON BLOOD PRESSURE CUFF | Andon Health Co, Ltd. | 2014-03-04 | Traditional | PDF ↗ |
| K130942 | LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF | Legacy Medical, Inc. | 2013-10-17 | Traditional | PDF ↗ |
| K123996 | RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF | Ge Medical Systems Information Technologies, Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K122058 | FLEXIPORT ECOCUFF | Welch Allyn, Inc. | 2012-11-05 | Traditional | PDF ↗ |
| K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF | Ge Medical Systems Information Technologies, Inc. | 2012-10-03 | Traditional | PDF ↗ |
| K122259 | BLOOD PRESSURE MONITOR WITH STETHOSCOPE | Hangzhou Reli-On Co., Ltd. | 2012-09-24 | Traditional | PDF ↗ |
| K120364 | UNIMED DISPOSABLE BLOOD PRESSURE CUFF | Unimed Medical Supplies, Inc. | 2012-05-04 | Traditional | PDF ↗ |
| K112544 | UNIMED BLOOD PRESSURE CUFF | Unimed Medical Supplies, Inc. | 2011-11-22 | Traditional | PDF ↗ |
| K103637 | ERKA. PERFECT-ANEROID | Erka Kallmeyer Medizintechnik GmbH | 2011-06-08 | Traditional | PDF ↗ |
| K102825 | BLOOD PRESSURE CUFF | APK Technology Co., Ltd. | 2011-03-02 | Traditional | PDF ↗ |
| K102792 | DISPOSABLE BLOOD PRESSURE CUF | Caremate Medical Device Co., Ltd. | 2011-01-26 | Traditional | PDF ↗ |
| K102823 | DISPOSABLE BLOOD PRESSURE CUFF | Wuxi Medical Instrument Factory | 2011-01-07 | Traditional | PDF ↗ |
| K101892 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- | Heine Optotechnik GmbH & Co. KG | 2010-08-27 | Traditional | PDF ↗ |
| K101972 | SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS | Solaris Medical Technology, Inc. | 2010-07-22 | Traditional | PDF ↗ |
| K092999 | NBP CUFF | Draeger Medical AG & Co. KG | 2009-11-24 | Traditional | PDF ↗ |
| K092245 | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 | Honsun (Nantong) Co., Ltd. | 2009-10-28 | Traditional | PDF ↗ |
| K092604 | LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX | Trimline Medical Products Corp. | 2009-10-21 | Abbreviated | PDF ↗ |
| K090014 | CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE | Caremate Medical Device Co., Ltd. | 2009-04-09 | Traditional | PDF ↗ |
| K090664 | DEVON ACCUBP CUFF | Devon Medical, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K082630 | VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES | Zefon Intl. | 2008-12-19 | Abbreviated | PDF ↗ |
| K080854 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 | Suntech Medical, Inc. | 2008-10-20 | Abbreviated | PDF ↗ |
| K082542 | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A | Cardicare Company, Ltd. | 2008-09-17 | Traditional | PDF ↗ |
| K080189 | TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX | Trimline Medical Products Corp. | 2008-08-15 | Abbreviated | PDF ↗ |
| K081951 | ANEROID SPHYGMOMANOMETER, MODEL KT-A01 | Wenzhou Kindcare Import & Export Co., Ltd. | 2008-08-15 | Traditional | PDF ↗ |
| K080366 | DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES | Zefon Intl. | 2008-06-09 | Abbreviated | PDF ↗ |
| K071244 | MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF | Medline Industries, Inc. | 2008-03-05 | Traditional | PDF ↗ |
| K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | Welch Allyn, Inc. | 2007-12-18 | Traditional | PDF ↗ |
| K063863 | ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER | Advantage Medical Cables, Inc. | 2007-03-20 | Traditional | PDF ↗ |
| K062238 | TYTAN BLOOD PRESSURE CUFF | Tytan Medical Corp. | 2006-09-21 | Traditional | PDF ↗ |
| K061962 | SURGI-CUF REUSABLE, RS SERIES | Ethox International | 2006-07-25 | Traditional | PDF ↗ |
| K060871 | AS101, BLOOD PRESSURE CUFF | Wenzhou Longwan Medical Instrument Company | 2006-06-09 | Traditional | PDF ↗ |
| K053006 | ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II | Rossmax Internationl , Ltd. | 2006-02-03 | Traditional | PDF ↗ |
| K051904 | ALL PURPOSE CUFF, MODEL 222APC | Suntech Medical, Inc. | 2005-09-09 | Abbreviated | PDF ↗ |
| K051539 | TRICOT BLOOD PRESSURE CUFF | Ya Horng Electronic Co., Ltd. | 2005-08-05 | Traditional | PDF ↗ |
| K051021 | ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A | Shanghai Lord International Trade Co., Ltd. | 2005-06-20 | Abbreviated | PDF ↗ |
| K043444 | MULTIPLE, MODEL KTJ-50 | Golden Horse Medical Equipment (Wuxi) Co. , Ltd. | 2005-02-22 | Traditional | PDF ↗ |
| K043286 | ANEROID SPHYGMOMANOMETER, MODEL BK2002 | Wenzhou Bokang Instrument Co.,Ltd | 2005-01-13 | Traditional | PDF ↗ |
| K041689 | POLYURETHANE BLOOD PRESSURE CUFFS | D. E. Hokanson, Inc. | 2004-08-06 | Special | PDF ↗ |
| K032568 | BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 | Med Textile, LLC | 2004-04-29 | Traditional | PDF ↗ |
| K040286 | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS | Ethox Corp. | 2004-03-15 | Abbreviated | PDF ↗ |
| K031195 | CUF-COVER (TM) | Ethox Corp. | 2003-10-10 | Traditional | PDF ↗ |
| K031416 | CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF | Clearmedical, Inc. | 2003-07-15 | Traditional | PDF ↗ |
| K023356 | KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR | Card Guard Scientific Survival , Ltd. | 2003-01-16 | Traditional | PDF ↗ |
| K022482 | SENSA-CUFF, MODELS INFANT, CHILD, ADULT | Ge Medical Systems Information Technologies | 2002-08-13 | Traditional | PDF ↗ |
| K012553 | GSIBP BLOOD PRESSURE CUFF | Globalshop, Inc. | 2001-08-17 | Abbreviated | PDF ↗ |
| K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | Welch Allyn, Inc. | 2001-08-17 | Abbreviated | PDF ↗ |
| K012444 | ABN ANEROID SPHYGMOMANOMETER | Pt. Sugih Instrumendo Abadi | 2001-08-16 | Traditional | PDF ↗ |
| K012194 | BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001-07-20 | Traditional | PDF ↗ |
Product code DXQ · Class II · Cardiovascular. Data: openFDA.