FLLClass II

Continuous Measurement Thermometer

21 CFR 880.2910 / General Hospital

FLL is the FDA product code for Continuous Measurement Thermometer, a class II device type, regulated under 21 CFR 880.2910. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 798 510(k) clearances under this code, the most recent dated 2026-06-05, and 18 recalls.

Classification record

Product code: FLL
Device name: Continuous Measurement Thermometer
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.
Regulation: 21 CFR 880.2910
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 798
Ingested recalls: 19

Clearances, product code FLL

By decision year

798 clearances under product code FLL with a decision year between 1976 and 2026, 2021 the highest year at 43.

Show the numbers

510(k) clearances under FDA product code FLL by decision year
Year	Clearances
1976	5
1977	10
1978	7
1979	8
1980	10
1981	8
1982	22
1983	23
1984	20
1985	35
1986	16
1987	10
1988	23
1989	10
1990	10
1991	10
1992	5
1993	7
1994	15
1995	27
1996	16
1997	8
1998	9
1999	12
2000	9
2001	20
2002	21
2003	22
2004	24
2005	14
2006	14
2007	15
2008	14
2009	13
2010	24
2011	20
2012	17
2013	14
2014	7
2015	3
2016	22
2017	16
2018	35
2019	22
2020	21
2021	43
2022	24
2023	17
2024	13
2025	6
2026	2

Applicants with the most clearances

Product code FLL

Applicants holding the most 510(k) clearances under product code FLL
Applicant	Clearances
Microlife Intellectual Property GmbH	20
R & D Batteries, Inc.	19
Taidoc Technology Corporation	16
Radiant Innovation Inc.	15
K-Jump Health Co., Ltd.	14
Mesure Technology Co., Ltd.	13
Mon-A-Therm, Inc.	11
Electromedics, Inc.	10
Respiratory Support Products, Inc.	10
Yellow Springs Instrument Co., Inc.	10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 446 companies shown, in name order