ClearanceBrief
Panels › General Hospital › Product code FLL · Class 2

Continuous Measurement Thermometer

Regulation 880.2910

2510(k)s in 12 months (798 all time)
1recalls in 12 months (19 all time)
18recalls that name a 510(k)
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Top companies in FLL

Company510(k)sRecalls
Microlife Intellectual Property GmbH200
R & D Batteries, Inc.190
Taidoc Technology Corporation160
Radiant Innovation, Inc.150
K-Jump Health Co., Ltd.140
Mesure Technology130
Avita Corporation110
Mon-A-Therm, Inc.110
Electromedics, Inc.100
Respiratory Support Products, Inc.100
Decided510(k)Device and applicantCode
Jun 5, 2026K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG);
Unimed Medical Supplies, Inc., CN
FLL
Jan 8, 2026K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
Shenzhen Med-Link Electronics Tech Co., Ltd., CN
FLL
Jun 23, 2025K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
Shenzhen AOJ Medical Technology Co., Ltd., CN
FLL
Jun 20, 2025K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
Shenzhen Medke Technology Co., Ltd., CN
FLL
May 22, 2025K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
FLL
Apr 25, 2025K243082Infrared Thermometer
Guangzhou Daxin Health Technology Co., Ltd., CN
FLL
Mar 14, 2025K250401AION TempShield™
Aion Biosystems, Inc.
FLL
Feb 14, 2025K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
Shenzhen Finicare Co., Ltd., CN
FLL
Oct 30, 2024K240333Wearable Digital Thermometer (T31)
Guangdong Genial Technology Co., Ltd., CN
FLL
Oct 25, 2024K240223FMT Disposable and Autoclavable Temperature Probes
Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi, TR
FLL
Sep 27, 2024K240220Aulisa Temperature Module (TM0002)
Taiwan Aulisa Medical Devices Technologies, Inc., TW
FLL
Aug 20, 2024K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
Covidien
FLL
Jun 21, 2024K233280SteadyTemp
Steadysense GmbH, AT
FLL
Jun 5, 2024K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
Radiant Innovation, Inc., TW
FLL
Apr 12, 2024K240109Medical electronic thermometer (FC01, FC02)
Zhuzhou Goldenhot Medical Technology Co., Ltd., CN
FLL
Apr 5, 2024K233192Wireless Smart Thermometer
Famidoc Technology Company Limited, CN
FLL
Apr 3, 2024K230889Digital Thermometer
Wenzhou Yosun Medical Technology Co.,Ltd, CN
FLL
Mar 1, 2024K240023Probe Covers (YF-001, YF-002)
Shenzhen YI Fang Blister Packaging Co., Ltd., CN
FLL
Feb 9, 2024K232473Infrared Thermometer: Model YJ600
Zhuhai Yueja Medical Device Technology Co., Ltd., CN
FLL
Feb 2, 2024K231625VitalDetect
Wellvii, Inc.
FLL
Jan 31, 2024K232678Digital Thermometer, Model T28, T28L
Guangdong Genial Technology Co., Ltd., CN
FLL
Dec 22, 2023K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356,
Alicn Medical Shenzhen, Inc., CN
FLL
Dec 5, 2023K222057THERMOCLICK
T&R BIOFAB CO., Ltd., KR
FLL
Oct 14, 2023K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
Shenzhen AOJ Medical Technology Co., Ltd., CN
FLL
Aug 25, 2023K223807Reusable Temperature Probe, Disposable Temperature Probe
Shenzhen Sino-K Medical Technology Co.,Ltd, CN
FLL
Aug 16, 2023K230298Celsi Monitor
Hadleigh Health Technologies
FLL
Aug 4, 2023K232010iTEMPSHIELD
Aion Biosystems, Inc.
FLL
Jul 21, 2023K223037Infrared Thermometer, Model: IR8807
Shen Zhen Rong Feng Technology Co., Ltd., CN
FLL
Jul 18, 2023K213100FMT Reusable Temperature Probes
Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti, TR
FLL
Jun 28, 2023K210924e-Celsius Medical System
Bodycap, FR
FLL
Jun 20, 2023K223522NC° Thermometer (Gen 3), Model Number: NCTG3
Xiamen Intretech, Inc., CN
FLL
Jun 7, 2023K222248Infrared Thermometer
Alicn Medical Shenzhen, Inc., CN
FLL
May 25, 2023K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
Circa Scientific, Inc.
FLL
May 10, 2023K223044Digital Thermometer (Model QT001)
Shen Zhen Rong Feng Technology Co., Ltd., CN
FLL
Feb 17, 2023K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
Iweecare Co., Ltd., TW
FLL
Feb 17, 2023K220276Infrared Thermometer TET-351
Truly Instrument Limited, CN
FLL
Feb 10, 2023K220657Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
Zhejiang Rongsheng Industrial Co., Ltd., CN
FLL
Jan 20, 2023K214077Digital Thermometer, Model: DT007, DT008
Guangzhou Berrcom Medical Device Co., Ltd., CN
FLL
Dec 20, 2022K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R an
Shenzhen AOJ Medical Technology Co., Ltd., CN
FLL
Dec 14, 2022K221800Infrared Thermometer (Model: Y20001, Y20002)
Zhangzhou Easepal Medical Science and Technology Co., Ltd., CN
FLL
Nov 28, 2022K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
Jkh Health Co., Ltd., CN
FLL
Oct 7, 2022K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
Shenzhen AOJ Medical Technology Co., Ltd., CN
FLL
Sep 27, 2022K221211Infrared thermometer
Shenzhen Yolanda Technology Co., Ltd., CN
FLL
Sep 12, 2022K220084Infrared Forehead Thermometer
Qingdao Yasee Medical Device Co., Ltd., CN
FLL
May 25, 2022K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
Shenzhen AOJ Medical Technology Co., Ltd., CN
FLL
May 12, 2022K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
Alicn Medical Shenzhen, Inc., CN
FLL
May 5, 2022K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
Shenzhen Pango Medical Electronics Co., Ltd., CN
FLL
May 5, 2022K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
Alicn Medical Shenzhen, Inc., CN
FLL
May 4, 2022K212257Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
Alicn Medical Shenzhen, Inc., CN
FLL
Apr 5, 2022K213746Digital thermometer, Model DT101, DT102
Guangzhou Berrcom Medical Device Co., Ltd., CN
FLL

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