FLL · Continuous Measurement Thermometer

Device class

Class II

Regulation 880.2910

Total clearances

126

2020-02-13 → 2026-06-05

Last 12 months

Unique sponsors

Definition

What is Continuous Measurement Thermometer

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.

Classification details

Medical specialty

General Hospital

Review panel

Regulation number

880.2910

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Alicn Medical Shenzhen, Inc.	6	0	2023-12-22
Andon Health Co, Ltd.	5	0	2022-01-28
Guangzhou Berrcom Medical Device Co., Ltd.	5	0	2023-01-20
Shenzhen AOJ Medical Technology Co., Ltd.	5	0	2025-06-23
Bioland Technology, Ltd.	3	0	2022-04-05
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	3	0	2025-05-22
Microlife Intellectual Property GmbH	2	0	2022-03-01
Wenzhou Yosun Medical Technology Co.,Ltd	2	0	2024-04-03
Aion Biosystems, Inc.	2	0	2025-03-14
Uni-Trend Technology (China) Co., Ltd.	2	0	2021-01-25
Circa Scientific, Inc.	2	0	2023-05-25
Hetaida Technology Co., Ltd.	2	0	2021-02-25
Shenzhen Med-Link Electronics Tech Co., Ltd.	2	1	2026-01-08
Shen Zhen Rong Feng Technology Co., Ltd.	2	0	2023-07-21
Guangdong Genial Technology Co., Ltd.	2	0	2024-10-30
Ningbo Ranor Medical Science & Technology Co., Ltd.	2	0	2020-07-16
Iweecare Co., Ltd.	2	0	2023-02-17
Shenzhen Bsx Technology Electronics Co., Ltd.	1	0	2021-07-23
Qingdao Yasee Medical Device Co., Ltd.	1	0	2022-09-12
Kangfu Medical Equipment Factory	1	0	2021-12-10
Hunan Honggao Electronic Technolofy Co., Ltd.	1	0	2021-02-26
Contec Medical Systems Co.,Ltd	1	0	2020-12-18
Guandong Genial Technology Co., Limited	1	0	2021-06-04
Zhuzhou Goldenhot Medical Technology Co., Ltd.	1	0	2024-04-12
Medline Industries, Inc.	1	0	2021-09-20

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
99000	CPT	—	Low	Handling/conveyance; thermometer is component of vital sign monitoring

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-05	K253162	Unimed Medical Supplies, Inc.	Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
2026-01-08	K251160	Shenzhen Med-Link Electronics Tech Co., Ltd.	Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
2025-06-23	K250470	Shenzhen AOJ Medical Technology Co., Ltd.	Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
2025-06-20	K243000	Shenzhen Medke Technology Co., Ltd.	Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
2025-05-22	K250878	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
2025-04-25	K243082	Guangzhou Daxin Health Technology Co., Ltd.	Infrared Thermometer
2025-03-14	K250401	Aion Biosystems, Inc.	AION TempShield
2025-02-14	K243136	Shenzhen Finicare Co., Ltd.	Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
2024-10-30	K240333	Guangdong Genial Technology Co., Ltd.	Wearable Digital Thermometer (T31)
2024-10-25	K240223	Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi	FMT Disposable and Autoclavable Temperature Probes
2024-09-27	K240220	Taiwan Aulisa Medical Devices Technologies, Inc.	Aulisa Temperature Module (TM0002)
2024-08-20	K240077	Covidien	Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
2024-06-21	K233280	Steadysense GmbH	SteadyTemp
2024-06-05	K240648	Radiant Innovation, Inc.	Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
2024-04-12	K240109	Zhuzhou Goldenhot Medical Technology Co., Ltd.	Medical electronic thermometer (FC01, FC02)
2024-04-05	K233192	Famidoc Technology Company Limited	Wireless Smart Thermometer
2024-04-03	K230889	Wenzhou Yosun Medical Technology Co.,Ltd	Digital Thermometer
2024-03-01	K240023	Shenzhen YI Fang Blister Packaging Co., Ltd.	Probe Covers (YF-001, YF-002)
2024-02-09	K232473	Zhuhai Yueja Medical Device Technology Co., Ltd.	Infrared Thermometer: Model YJ600
2024-02-02	K231625	Wellvii, Inc.	VitalDetect
2024-01-31	K232678	Guangdong Genial Technology Co., Ltd.	Digital Thermometer, Model T28, T28L
2023-12-22	K232338	Alicn Medical Shenzhen, Inc.	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
2023-12-05	K222057	T&R BIOFAB CO., Ltd.	THERMOCLICK
2023-10-14	K232128	Shenzhen AOJ Medical Technology Co., Ltd.	Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
2023-08-25	K223807	Shenzhen Sino-K Medical Technology Co.,Ltd	Reusable Temperature Probe, Disposable Temperature Probe