510(k) · Cleared

Cleared

Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818 and TM818A

K102935510(k) TraditionalCleared May 27, 2011235-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

Kingtech Enterprise, Ltd. · FLL Continuous Measurement Thermometer

Cleared on May 27, 2011 as substantially equivalent to K011254 (Mesure Technology, 2001) after a 235-day review. Its family tree reaches back 1 generation to 2001.

Decided: May 27, 2011
Review: 235 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011254 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011254 Ear Thermometer, Models ST613C and ST613FMesure Technology · 2001
This deviceK102935 Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A…Kingtech Enterprise, Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011254	Ear Thermometer, Models ST613C and ST613F	Mesure Technology	2001	—
0 (this device)	K102935	Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818…	Kingtech Enterprise, Ltd.	2011	—

FIG. 1 — Lineage of K102935, 2001–2011Source: 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
*	K011254	Ear Thermometer, Models ST613C and ST613F Summary page 2 …Thermometer, models TM8 1OA, TM8 108B, TM8 17, TM8 18, TMS18A, TM819 and TM820 are substantially equivalent to the Measure Technology, models: ST613C and ST613F (K01 1254). 7. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of IR-04MT ar…	Mesure Technology	2001	—

Also cleared against K011254: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
3 other devices also cite its predicate K011254.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 KINGTECH Infrared Ear Thermometer, models: TMSIOA, TM81OB3, TM8IY, TM8 18, TM8LSA, TMS 19, and TM82O are battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The devices are reusable and intended for home use on people at all ages.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102935 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102935: Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818 and TM818A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102935

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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