Product code FLL
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 |
| K250401 | AION TempShield™ | Aion Biosystems, Inc. | 2025-03-14 |
| 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 |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 |
| K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | 2024-08-20 |
| K233280 | SteadyTemp | Steadysense GmbH | 2024-06-21 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd | 2024-04-03 |
| K240023 | Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. | 2024-03-01 |
| K232473 | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2024-02-09 |
| K231625 | VitalDetect | Wellvii, Inc. | 2024-02-02 |
| K232678 | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | 2024-01-31 |
| 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 |
| K222057 | THERMOCLICK | T&R BIOFAB CO., Ltd. | 2023-12-05 |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-10-14 |
| K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-25 |
| K230298 | Celsi Monitor | Hadleigh Health Technologies | 2023-08-16 |
| K232010 | iTEMPSHIELD | Aion Biosystems, Inc. | 2023-08-04 |
| K223037 | Infrared Thermometer, Model: IR8807 | Shen Zhen Rong Feng Technology Co., Ltd. | 2023-07-21 |
| K213100 | FMT Reusable Temperature Probes | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti | 2023-07-18 |
| K210924 | e-Celsius Medical System | Bodycap | 2023-06-28 |
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| 00840986019715 | Premier Value | PHARMACY VALUE ALLIANCE, LLC | 2016-09-20 |
| 00840986027512 | Premier Value | PHARMACY VALUE ALLIANCE, LLC | 2016-09-20 |
| 20885380023856 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-12 |
| 20885380023849 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-12 |