Product code FLL

Current FDA Classification

Device name
Continuous Measurement Thermometer
Medical specialty
General Hospital
Device class
2
Regulation number
880.2910
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
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.

Related 510(k) Records

510(k)DeviceApplicantDecision date
K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.2026-01-08
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.2025-06-23
K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.2025-06-20
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-05-22
K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.2025-04-25
K250401AION TempShield™Aion Biosystems, Inc.2025-03-14
K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)Shenzhen Finicare Co., Ltd.2025-02-14
K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd.2024-10-30
K240223FMT Disposable and Autoclavable Temperature ProbesMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi2024-10-25
K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.2024-09-27
K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)Covidien2024-08-20
K233280SteadyTempSteadysense GmbH2024-06-21
K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc.2024-06-05
K240109Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd.2024-04-12
K233192Wireless Smart ThermometerFamidoc Technology Company Limited2024-04-05
K230889Digital ThermometerWenzhou Yosun Medical Technology Co.,Ltd2024-04-03
K240023Probe Covers (YF-001, YF-002)Shenzhen YI Fang Blister Packaging Co., Ltd.2024-03-01
K232473Infrared Thermometer: Model YJ600Zhuhai Yueja Medical Device Technology Co., Ltd.2024-02-09
K231625VitalDetectWellvii, Inc.2024-02-02
K232678Digital Thermometer, Model T28, T28LGuangdong Genial Technology Co., Ltd.2024-01-31
K232338Electronic 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-F383Alicn Medical Shenzhen, Inc.2023-12-22
K222057THERMOCLICKT&R BIOFAB CO., Ltd.2023-12-05
K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd.2023-10-14
K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd2023-08-25
K230298Celsi MonitorHadleigh Health Technologies2023-08-16
K232010iTEMPSHIELDAion Biosystems, Inc.2023-08-04
K223037Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd.2023-07-21
K213100FMT Reusable Temperature ProbesMetko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti2023-07-18
K210924e-Celsius Medical SystemBodycap2023-06-28
K223522NC° Thermometer (Gen 3), Model Number: NCTG3Xiamen Intretech, Inc.2023-06-20

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