FDA Product Code
FDA Product Code FLL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2910
510(k) Clearances — 798 records · page 1 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | 2026-06-05 | Traditional | PDF ↗ |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 | Traditional | PDF ↗ |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 | Traditional | PDF ↗ |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 | Traditional | PDF ↗ |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 | Traditional | PDF ↗ |
| K250401 | AION TempShield | Aion Biosystems, Inc. | 2025-03-14 | Traditional | PDF ↗ |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | 2025-02-14 | Traditional | PDF ↗ |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 | Traditional | PDF ↗ |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 | Traditional | PDF ↗ |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 | Traditional | PDF ↗ |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | 2024-08-20 | Traditional | PDF ↗ |
| K233280 | SteadyTemp | Steadysense GmbH | 2024-06-21 | Traditional | PDF ↗ |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 | Traditional | PDF ↗ |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 | Traditional | PDF ↗ |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 | Traditional | PDF ↗ |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd | 2024-04-03 | Traditional | PDF ↗ |
| K240023 | Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. | 2024-03-01 | Traditional | PDF ↗ |
| K232473 | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2024-02-09 | Traditional | PDF ↗ |
| K231625 | VitalDetect | Wellvii, Inc. | 2024-02-02 | Traditional | PDF ↗ |
| K232678 | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | 2024-01-31 | Traditional | PDF ↗ |
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | Alicn Medical Shenzhen, Inc. | 2023-12-22 | Traditional | PDF ↗ |
| K222057 | THERMOCLICK | T&R BIOFAB CO., Ltd. | 2023-12-05 | Traditional | PDF ↗ |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-10-14 | Traditional | PDF ↗ |
| K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-25 | Traditional | PDF ↗ |
| K230298 | Celsi Monitor | Hadleigh Health Technologies | 2023-08-16 | Traditional | PDF ↗ |
| K232010 | iTEMPSHIELD | Aion Biosystems, Inc. | 2023-08-04 | Traditional | PDF ↗ |
| K223037 | Infrared Thermometer, Model: IR8807 | Shen Zhen Rong Feng Technology Co., Ltd. | 2023-07-21 | Traditional | PDF ↗ |
| K213100 | FMT Reusable Temperature Probes | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti | 2023-07-18 | Traditional | PDF ↗ |
| K210924 | e-Celsius Medical System | Bodycap | 2023-06-28 | Traditional | PDF ↗ |
| K223522 | NC° Thermometer (Gen 3), Model Number: NCTG3 | Xiamen Intretech, Inc. | 2023-06-20 | Traditional | PDF ↗ |
| K222248 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | 2023-06-07 | Traditional | PDF ↗ |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, Inc. | 2023-05-25 | Traditional | PDF ↗ |
| K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | 2023-05-10 | Traditional | PDF ↗ |
| K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | Iweecare Co., Ltd. | 2023-02-17 | Traditional | PDF ↗ |
| K220276 | Infrared Thermometer TET-351 | Truly Instrument Limited | 2023-02-17 | Traditional | PDF ↗ |
| K220657 | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) | Zhejiang Rongsheng Industrial Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K214077 | Digital Thermometer, Model: DT007, DT008 | Guangzhou Berrcom Medical Device Co., Ltd. | 2023-01-20 | Traditional | PDF ↗ |
| K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-12-20 | Traditional | PDF ↗ |
| K221800 | Infrared Thermometer (Model: Y20001, Y20002) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022-12-14 | Traditional | PDF ↗ |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | Jkh Health Co., Ltd. | 2022-11-28 | Traditional | PDF ↗ |
| K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K221211 | Infrared thermometer | Shenzhen Yolanda Technology Co., Ltd. | 2022-09-27 | Traditional | PDF ↗ |
| K220084 | Infrared Forehead Thermometer | Qingdao Yasee Medical Device Co., Ltd. | 2022-09-12 | Traditional | PDF ↗ |
| K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | Alicn Medical Shenzhen, Inc. | 2022-05-12 | Traditional | PDF ↗ |
| K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | Shenzhen Pango Medical Electronics Co., Ltd. | 2022-05-05 | Traditional | PDF ↗ |
| K210565 | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 | Alicn Medical Shenzhen, Inc. | 2022-05-05 | Traditional | PDF ↗ |
| K212257 | Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 | Alicn Medical Shenzhen, Inc. | 2022-05-04 | Traditional | PDF ↗ |
| K213011 | Infrared Thermometer (model: E201) | Bioland Technology, Ltd. | 2022-04-05 | Traditional | PDF ↗ |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) | Taidoc Technology Corporation | 2022-04-05 | Traditional | PDF ↗ |
| K213746 | Digital thermometer, Model DT101, DT102 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-04-05 | Traditional | PDF ↗ |
| K210171 | Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) | Sichuan Youkede Medical Equipment Co.,Ltd | 2022-03-18 | Traditional | PDF ↗ |
| K213038 | Infrared Forehead Thermometer, model: HS-9802D | Jiaxing Shangjia Intelligence Technology Co., Ltd. | 2022-03-10 | Traditional | PDF ↗ |
| K212945 | Sterile Disposable Temperature Probe | Shenzhen Envisen Industry Co., Ltd. | 2022-03-01 | Traditional | PDF ↗ |
| K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | Microlife Intellectual Property GmbH | 2022-03-01 | Traditional | PDF ↗ |
| K213084 | Ear Thermometer, Model ET005, ET008, ET009 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-02-25 | Traditional | PDF ↗ |
| K213079 | Ear Thermometer, Model ET001 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K212598 | iHealth infrared Ear thermometer PT5 | Andon Health Co, Ltd. | 2022-01-28 | Abbreviated | PDF ↗ |
| K213082 | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-01-28 | Traditional | PDF ↗ |
| K211752 | Infrared Thermometer | Beijing Choice Electronic Technology Co., Ltd. | 2022-01-21 | Traditional | PDF ↗ |
| K210564 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | 2022-01-07 | Traditional | PDF ↗ |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, LLC | 2021-12-17 | Traditional | PDF ↗ |
| K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 | Kangfu Medical Equipment Factory | 2021-12-10 | Traditional | PDF ↗ |
| K211629 | Infrared forehead thermometer LD-FT-100B | Honsun (Nantong) Co., Ltd. | 2021-12-08 | Traditional | PDF ↗ |
| K211744 | Non-Contact Infrared Thermometer, model HL710H | Health & Life Co., Ltd. | 2021-11-24 | Traditional | PDF ↗ |
| K201032 | Phoenix Digital Thermometer | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | 2021-10-29 | Traditional | PDF ↗ |
| K203497 | Infrared Thermometer (Model K9) | Kangzhan Communication Electronics Co., Ltd. | 2021-10-08 | Traditional | PDF ↗ |
| K202481 | ThermArt (Model IR-EFT) | Comper Chuangxiang (Beijing) Technology Co., Ltd. | 2021-09-28 | Traditional | PDF ↗ |
| K203731 | DT100 Digital Thermometer | Smart Technology Co., Ltd. | 2021-09-26 | Traditional | PDF ↗ |
| K203662 | Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 | Yibin Junxin Electronics Technology Co., Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K211931 | Medline Digital Thermometer Non-Lubricated Probe Sheath | Medline Industries, Inc. | 2021-09-20 | Traditional | PDF ↗ |
| K210118 | INFRARED BODY THERMOMETER (Model: YK-001) | Longnan Renzhong Medical Equipment Co., Ltd. | 2021-09-15 | Traditional | PDF ↗ |
| K211352 | Electronic Thermometer (XHF2001, XHF2002) | Putian Hanjiang Huafeng Plastic Co., Ltd. | 2021-09-09 | Traditional | PDF ↗ |
| K211583 | Infrared Thermometer, Model: HW-1 | Dongguan Simzo Electronic Technology Co., Ltd. | 2021-09-03 | Traditional | PDF ↗ |
| K203636 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG | Jkh USA, LLC | 2021-08-31 | Traditional | PDF ↗ |
| K203643 | Sensatronic Reusable Temperature Probes | Sensatronic GmbH | 2021-08-11 | Traditional | PDF ↗ |
| K203431 | Disposable Ear Thermometer Probe Cover | Huaian Zhongxin Packing Material Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K202296 | Infrared Forehead Thermometer, Model BSX976 | Shenzhen Bsx Technology Electronics Co., Ltd. | 2021-07-23 | Traditional | PDF ↗ |
| K202603 | Temp Pal | Iweecare Co., Ltd. | 2021-07-22 | Traditional | PDF ↗ |
| K202741 | Infrared Forehead Thermometer | Shenzhen Combei Technology Co., Ltd. | 2021-07-07 | Traditional | PDF ↗ |
| K202440 | Infrared Thermometer | Shenzhen Sonida Digital Technology Co., Ltd. | 2021-06-17 | Traditional | PDF ↗ |
| K203215 | Radius T wearable thermometer | Masimo Corporation | 2021-06-11 | Traditional | PDF ↗ |
| K210014 | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) | Guandong Genial Technology Co., Limited | 2021-06-04 | Traditional | PDF ↗ |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2021-05-20 | Traditional | PDF ↗ |
| K203454 | Infrared Thermometer | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-04-29 | Traditional | PDF ↗ |
| K203170 | Infrared Thermometer Models: DT-8806S, DT-8807S | Shenzhen Everbest Machinery Industry Co., Ltd. | 2021-04-16 | Traditional | PDF ↗ |
| K201879 | Digital Thermometer Model T103, T104 | Bioland Technology, Ltd. | 2021-03-31 | Traditional | PDF ↗ |
| K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 | Shenzhen Juzhong Technology Co., Ltd. | 2021-03-22 | Traditional | PDF ↗ |
| K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | Shenzhen Zhengkang Technology Co., Ltd. | 2021-03-12 | Traditional | PDF ↗ |
| K202591 | Body Infrared Thermometer HT-820D | Dongguan Xintai Instrument Co., Ltd. | 2021-03-09 | Traditional | PDF ↗ |
| K201508 | Infrared Thermometer | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-03-09 | Traditional | PDF ↗ |
| K202753 | iHealth Wireless No-Touch Forehead Thermometer | Andon Health Co, Ltd. | 2021-03-08 | Traditional | PDF ↗ |
| K202111 | Medical infrared forehead thermometer | Hunan Honggao Electronic Technolofy Co., Ltd. | 2021-02-26 | Traditional | PDF ↗ |
| K202420 | Infrared Forehead Thermometer | Conmo Electronic Company Limited | 2021-02-25 | Traditional | PDF ↗ |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | Hetaida Technology Co., Ltd. | 2021-02-25 | Special | PDF ↗ |
| K202687 | Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-02-18 | Traditional | PDF ↗ |
| K202368 | Infrared Thermometer | Shandong Bittel Intelligent Technology Co., Ltd. | 2021-02-12 | Traditional | PDF ↗ |
| K201536 | Infrared Forehead Thermometer | Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. | 2021-02-10 | Traditional | PDF ↗ |
| K203747 | Non-Contact Forehead Thermometer (Models UT306H & UT308H) | Uni-Trend Technology (China) Co., Ltd. | 2021-01-25 | Traditional | PDF ↗ |
Product code FLL · Class II · General Hospital. Data: openFDA.