510(k) · Cleared

Cleared

Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.

K072641510(k) TraditionalCleared Nov 1, 200744-day reviewClass II21 CFR 880.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Famidoc Technology Co., Ltd. · FLL Continuous Measurement Thermometer

Cleared on Nov 1, 2007 as substantially equivalent to K010238 (Actherm, Inc., 2001) after a 44-day review. Its family tree reaches back 1 generation to 2001. 9 later devices descend from it.

Decided: Nov 1, 2007
Review: 44 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010238 (2001). 9 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
This deviceK072641 Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
Descendant · cites it directly · 8 of its ownK101387 Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010
Descendant · 2 generations on · 2 of its ownK132514 Kinsa Smart ThermometerKinsa, Inc. · 2013
Descendant · 2 generations on · 1 of its ownK203731 DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021
Descendant · 2 generations on · 1 of its ownK190990 Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019
Descendant · 3 generations on · 1 of its ownK152739 Electronic ThermometerGuangdong Biolight Meditech Co., Ltd. · 2016

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010high 2 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all

K101387Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010 · cites it directly8descendants
K132514Kinsa Smart ThermometerKinsa, Inc. · 2013 · 2 generations on2descendants
K203731DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021 · 2 generations on1descendant
K190990Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019 · 2 generations on1descendant
K152739Electronic ThermometerGuangdong Biolight Meditech Co., Ltd. · 2016 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010238	Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+…	Actherm, Inc.	2001	—
0 (this device)	K072641	Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.	Famidoc Technology Co., Ltd.	2007	—
+1	K101387	Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN	Fudakang Industries Co., Ltd.	2010	—
+2	K132514	Kinsa Smart Thermometer	Kinsa, Inc.	2013	—
+2	K203731	DT100 Digital Thermometer	Smart Technology Co., Ltd.	2021	—
+2	K190990	Digital Thermometer	Xiamen Ants Bro Technology Co., Ltd.	2019	—
+3	K152739	Electronic Thermometer	Guangdong Biolight Meditech Co., Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	1	0
2016	1	0
2017	1	0
2018	1	0
2019	1	0
2021	2	0
2023	1	0

FIG. 1 — Lineage of K072641, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FLL device

#1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K010238	Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+… Summary page 3 …Model FDTH-VO-1l FDTH-VO-2, FDTH-VO-3, FDTH-VO-4 are substantially equivalent to Actherm digital clinical thermometer Model: ACT 2000, It's 510(k) number is K010238. They are very similar in design principle, intended use, functions, material and the adopting applicable standards. Onl…	Actherm, Inc.	2001	—

Also cleared against K010238: 3 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101387	Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN	Fudakang Industries Co., Ltd.	2010	8

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K101387 (Fudakang Industries Co., Ltd., 2010) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K010238.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	81	0	4
2008	14	59	0	13
2009	13	84	0	9
2010	24	88	0	9
2011	20	113	1	18
2012	17	126	0	26
2013	14	149	0	16
2014	7	199	0	54
2015	3	270	1	53
2016	22	157	0	58
2017	16	174	2	118
2018	35	209	1	51
2019	22	198	5	52
2020	21	194	0	53
2021	43	218	0	115
2022	24	218	0	142
2023	17	295	0	101
2024	13	223	0	118
2025	6	131	1	73
2026	2	—	1	—

What is it indicated for?

Famidoc Digital Clinical Thermometers are intended for the measurement and monitoring of human body temperature, by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072641: Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072641

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026