Atlas FDA

FLL

798 FDA 510(k) clearances · Product code

108 daysmedian time to decision
294 days90th percentile
798clearances measured

FDA profile

Official device name
Continuous Measurement Thermometer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2910
Medical specialty
General Hospital
Flags
Third-party review eligible
FDA definition
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Adverse events (MAUDE)
2021: 115 · 2022: 142 · 2023: 101 · 2024: 118 · 2025: 75 · 2026: 47
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) (K253162)Unimed Medical Supplies, Inc.2026-06-05
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (K251160)Shenzhen Med-Link Electronics Tech Co., Ltd.2026-01-08
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (K250470)Shenzhen AOJ Medical Technology Co., Ltd.2025-06-23
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) (K243000)Shenzhen Medke Technology Co., Ltd.2025-06-20
YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (K250878)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-05-22
Infrared Thermometer (K243082)Guangzhou Daxin Health Technology Co., Ltd.2025-04-25
AION TempShield™ (K250401)Aion Biosystems, Inc.2025-03-14
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) (K243136)Shenzhen Finicare Co., Ltd.2025-02-14
Wearable Digital Thermometer (T31) (K240333)Guangdong Genial Technology Co., Ltd.2024-10-30
FMT Disposable and Autoclavable Temperature Probes (K240223)Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi2024-10-25
Aulisa Temperature Module (TM0002) (K240220)Taiwan Aulisa Medical Devices Technologies, Inc.2024-09-27
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) (K240077)Covidien2024-08-20
SteadyTemp (K233280)Steadysense GmbH2024-06-21
Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) (K240648)Radiant Innovation, Inc.2024-06-05
Medical electronic thermometer (FC01, FC02) (K240109)Zhuzhou Goldenhot Medical Technology Co., Ltd.2024-04-12
Wireless Smart Thermometer (K233192)Famidoc Technology Company Limited2024-04-05
Digital Thermometer (K230889)Wenzhou Yosun Medical Technology Co.,Ltd2024-04-03
Probe Covers (YF-001, YF-002) (K240023)Shenzhen YI Fang Blister Packaging Co., Ltd.2024-03-01
Infrared Thermometer: Model YJ600 (K232473)Zhuhai Yueja Medical Device Technology Co., Ltd.2024-02-09
VitalDetect (K231625)Wellvii, Inc.2024-02-02
Digital Thermometer, Model T28, T28L (K232678)Guangdong Genial Technology Co., Ltd.2024-01-31
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 (K232338)Alicn Medical Shenzhen, Inc.2023-12-22
THERMOCLICK (K222057)T&R BIOFAB CO., Ltd.2023-12-05
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) (K232128)Shenzhen AOJ Medical Technology Co., Ltd.2023-10-14
Reusable Temperature Probe, Disposable Temperature Probe (K223807)Shenzhen Sino-K Medical Technology Co.,Ltd2023-08-25
Celsi Monitor (K230298)Hadleigh Health Technologies2023-08-16
iTEMPSHIELD (K232010)Aion Biosystems, Inc.2023-08-04
Infrared Thermometer, Model: IR8807 (K223037)Shen Zhen Rong Feng Technology Co., Ltd.2023-07-21
FMT Reusable Temperature Probes (K213100)Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti2023-07-18
e-Celsius Medical System (K210924)Bodycap2023-06-28
NC° Thermometer (Gen 3), Model Number: NCTG3 (K223522)Xiamen Intretech, Inc.2023-06-20
Infrared Thermometer (K222248)Alicn Medical Shenzhen, Inc.2023-06-07
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (K222311)Circa Scientific, Inc.2023-05-25
Digital Thermometer (Model QT001) (K223044)Shen Zhen Rong Feng Technology Co., Ltd.2023-05-10
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 (K222588)Iweecare Co., Ltd.2023-02-17
Infrared Thermometer TET-351 (K220276)Truly Instrument Limited2023-02-17
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) (K220657)Zhejiang Rongsheng Industrial Co., Ltd.2023-02-10
Digital Thermometer, Model: DT007, DT008 (K214077)Guangzhou Berrcom Medical Device Co., Ltd.2023-01-20
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 (K221039)Shenzhen AOJ Medical Technology Co., Ltd.2022-12-20
Infrared Thermometer (Model: Y20001, Y20002) (K221800)Zhangzhou Easepal Medical Science and Technology Co., Ltd.2022-12-14
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 (K211050)Jkh Health Co., Ltd.2022-11-28
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 (K221170)Shenzhen AOJ Medical Technology Co., Ltd.2022-10-07
Infrared thermometer (K221211)Shenzhen Yolanda Technology Co., Ltd.2022-09-27
Infrared Forehead Thermometer (K220084)Qingdao Yasee Medical Device Co., Ltd.2022-09-12
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E (K213485)Shenzhen AOJ Medical Technology Co., Ltd.2022-05-25
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 (K210937)Alicn Medical Shenzhen, Inc.2022-05-12
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 (K210565)Alicn Medical Shenzhen, Inc.2022-05-05
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 (K212346)Shenzhen Pango Medical Electronics Co., Ltd.2022-05-05
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 (K212257)Alicn Medical Shenzhen, Inc.2022-05-04
Infrared Thermometer (model: E201) (K213011)Bioland Technology, Ltd.2022-04-05
Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) (K200946)Taidoc Technology Corporation2022-04-05
Digital thermometer, Model DT101, DT102 (K213746)Guangzhou Berrcom Medical Device Co., Ltd.2022-04-05
Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) (K210171)Sichuan Youkede Medical Equipment Co.,Ltd2022-03-18
Infrared Forehead Thermometer, model: HS-9802D (K213038)Jiaxing Shangjia Intelligence Technology Co., Ltd.2022-03-10
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) (K211776)Microlife Intellectual Property GmbH2022-03-01
Sterile Disposable Temperature Probe (K212945)Shenzhen Envisen Industry Co., Ltd.2022-03-01
Ear Thermometer, Model ET005, ET008, ET009 (K213084)Guangzhou Berrcom Medical Device Co., Ltd.2022-02-25
Ear Thermometer, Model ET001 (K213079)Guangzhou Berrcom Medical Device Co., Ltd.2022-02-18
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 (K213082)Guangzhou Berrcom Medical Device Co., Ltd.2022-01-28
iHealth infrared Ear thermometer PT5 (K212598)Andon Health Co, Ltd.2022-01-28
Infrared Thermometer (K211752)Beijing Choice Electronic Technology Co., Ltd.2022-01-21
Infrared Thermometer (K210564)Alicn Medical Shenzhen, Inc.2022-01-07
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (K200943)Circa Scientific, LLC2021-12-17
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 (K201600)Kangfu Medical Equipment Factory2021-12-10
Infrared forehead thermometer LD-FT-100B (K211629)Honsun (Nantong) Co., Ltd.2021-12-08
Non-Contact Infrared Thermometer, model HL710H (K211744)Health & Life Co., Ltd.2021-11-24
Phoenix Digital Thermometer (K201032)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.2021-10-29
Infrared Thermometer (Model K9) (K203497)Kangzhan Communication Electronics Co., Ltd.2021-10-08
ThermArt (Model IR-EFT) (K202481)Comper Chuangxiang (Beijing) Technology Co., Ltd.2021-09-28
DT100 Digital Thermometer (K203731)Smart Technology Co., Ltd.2021-09-26
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 (K203662)Yibin Junxin Electronics Technology Co., Ltd.2021-09-23
Medline Digital Thermometer Non-Lubricated Probe Sheath (K211931)Medline Industries, Inc.2021-09-20
INFRARED BODY THERMOMETER (Model: YK-001) (K210118)Longnan Renzhong Medical Equipment Co., Ltd.2021-09-15
Electronic Thermometer (XHF2001, XHF2002) (K211352)Putian Hanjiang Huafeng Plastic Co., Ltd.2021-09-09
Infrared Thermometer, Model: HW-1 (K211583)Dongguan Simzo Electronic Technology Co., Ltd.2021-09-03
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 (K203636)Jkh USA, LLC2021-08-31
Sensatronic Reusable Temperature Probes (K203643)Sensatronic GmbH2021-08-11
Disposable Ear Thermometer Probe Cover (K203431)Huaian Zhongxin Packing Material Co., Ltd.2021-07-28
Infrared Forehead Thermometer, Model BSX976 (K202296)Shenzhen Bsx Technology Electronics Co., Ltd.2021-07-23
Temp Pal (K202603)Iweecare Co., Ltd.2021-07-22
Infrared Forehead Thermometer (K202741)Shenzhen Combei Technology Co., Ltd.2021-07-07
Infrared Thermometer (K202440)Shenzhen Sonida Digital Technology Co., Ltd.2021-06-17
Radius T wearable thermometer (K203215)Masimo Corporation2021-06-11
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) (K210014)Guandong Genial Technology Co., Limited2021-06-04
YUWELL infrared ear thermometer: YHT101, YHT200 (K203583)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2021-05-20
Infrared Thermometer (K203454)Shandong Zhushi Pharmaceutical Group Co., Ltd.2021-04-29
Infrared Thermometer Models: DT-8806S, DT-8807S (K203170)Shenzhen Everbest Machinery Industry Co., Ltd.2021-04-16
Digital Thermometer Model T103, T104 (K201879)Bioland Technology, Ltd.2021-03-31
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 (K202009)Shenzhen Juzhong Technology Co., Ltd.2021-03-22
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 (K203707)Shenzhen Zhengkang Technology Co., Ltd.2021-03-12
Body Infrared Thermometer HT-820D (K202591)Dongguan Xintai Instrument Co., Ltd.2021-03-09
Infrared Thermometer (K201508)Dongguan Prestige Sporting Goods Co., Ltd.2021-03-09
iHealth Wireless No-Touch Forehead Thermometer (K202753)Andon Health Co, Ltd.2021-03-08
Medical infrared forehead thermometer (K202111)Hunan Honggao Electronic Technolofy Co., Ltd.2021-02-26
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C (K203332)Hetaida Technology Co., Ltd.2021-02-25
Infrared Forehead Thermometer (K202420)Conmo Electronic Company Limited2021-02-25
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 (K202687)Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.2021-02-18
Infrared Thermometer (K202368)Shandong Bittel Intelligent Technology Co., Ltd.2021-02-12
Infrared Forehead Thermometer (K201536)Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.2021-02-10
Non-Contact Forehead Thermometer (Models UT306H & UT308H) (K203747)Uni-Trend Technology (China) Co., Ltd.2021-01-25
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