510(k) · Cleared

Cleared

Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B

K081445510(k) TraditionalCleared Aug 11, 200881-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

Taidoc Technology Corporation · FLL Continuous Measurement Thermometer

Cleared on Aug 11, 2008 as substantially equivalent to K061800 (Taidoc Technology Corporation, 2006) after an 81-day review. Its family tree reaches back 1 generation to 2006. 13 later devices descend from it.

Decided: Aug 11, 2008
Review: 81 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K061800 (2006). 13 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK061800 Clever TD-1112 Ear/Skin/Surface IR ThermometerTaidoc Technology Corporation · 2006
This deviceK081445 Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261BTaidoc Technology Corporation · 2008
Descendant · cites it directly · 7 of its ownK113159 U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012
Descendant · 2 generations on · 2 of its ownK131771 Caregiver Professional Clinical Thermometer, Pro-TF SeriesThermomedics, Inc. · 2013
Descendant · 2 generations on · 2 of its ownK122221 Nexus IR30 Non-Contact Infrared Forehead ThermometerTaidoc Technology Corporation · 2013
Descendant · cites it directly · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
Descendant · 3 generations on · 0 of its ownK200946 Clever Forehead Thermometer / Clever Medical Forehead Thermometer…Taidoc Technology Corporation · 2022

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2010high 3 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 13 · See all

K113159U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012 · cites it directly7descendants
K131771Caregiver Professional Clinical Thermometer, Pro-TF SeriesThermomedics, Inc. · 2013 · 2 generations on2descendants
K122221Nexus IR30 Non-Contact Infrared Forehead ThermometerTaidoc Technology Corporation · 2013 · 2 generations on2descendants
K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · cites it directly1descendant
K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)Taidoc Technology Corporation · 2022 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K061800	Clever TD-1112 Ear/Skin/Surface IR Thermometer	Taidoc Technology Corporation	2006	—
0 (this device)	K081445	Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B	Taidoc Technology Corporation	2008	—
+1	K113159	U-Right TD-1240 Thermometer	Taidoc Technology Corporation	2012	—
+2	K131771	Caregiver Professional Clinical Thermometer, Pro-TF Series	Thermomedics, Inc.	2013	—
+2	K122221	Nexus IR30 Non-Contact Infrared Forehead Thermometer	Taidoc Technology Corporation	2013	—
+1	K101259	V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002	Taidoc Technology Corporation	2010	—
+3	K200946	Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model…	Taidoc Technology Corporation	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2012	3	0
2013	3	0
2014	1	0
2016	1	0
2018	2	0
2022	1	0

FIG. 1 — Lineage of K081445, 2006–2022Source: 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

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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
*	K061800	Clever TD-1112 Ear/Skin/Surface IR Thermometer Summary page 1 …Thermometer Common/Usual Name: - Clinical electronic thermometer Manufacturer TaiDoc Technology Corporation 510 (k)Number K061800 ix Page 2-of-2…	Taidoc Technology Corporation	2006	—

Also cleared against K061800: 1 other device →

What descends from it? (13)

See all 13

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113159	U-Right TD-1240 Thermometer	Taidoc Technology Corporation	2012	7
K101259	V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002	Taidoc Technology Corporation	2010	1
K121118	Fora Comfortscan Ear Thermometer	Foracare, Inc.	2012	0
K120712	Fora Comfortscan Ear Thermometer	Taidoc Technology Corporation	2012	0
K100942	U-Right Ear Themometer, Models TD-1115 and TD-1118	Taidoc Technology Corporation	2010	0

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, K113159 (Taidoc Technology Corporation, 2012) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K061800.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

The Fora ComfortScan Ear Thermometer is an electronic thermometer using

an infrared sensor to detect human body temperature from the ear canal on

people of all ages and for use in the home. It is also available to detect object's

surface temperature including human skin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081445 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081445: Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081445

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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