510(k) · Cleared

Cleared

Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200

K081788510(k) TraditionalCleared Dec 17, 2008176-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

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

Cleared on Dec 17, 2008 as substantially equivalent to K011059 (Radiant Innovation, Inc., 2001) after a 176-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Dec 17, 2008
Review: 176 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011059 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
This deviceK081788 Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200Innochips Technology Co., Ltd. · 2008
Descendant · cites it directly · 0 of its ownK111703 Infrared Ear TherometerFudakang Industrial Co., Ltd. · 2012

Most influential descendants

Showing 1 of 1 · See all

K111703Infrared Ear TherometerFudakang Industrial Co., Ltd. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011059	Infared Ear Thermometer, Model TH8 Series	Radiant Innovation, Inc.	2001	—
0 (this device)	K081788	Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200	Innochips Technology Co., Ltd.	2008	—
+1	K111703	Infrared Ear Therometer	Fudakang Industrial Co., Ltd.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K081788, 2001–2012Source: 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
*	K011059	Infared Ear Thermometer, Model TH8 Series Summary page 1 …al Electronic Thermometer / Infrared Ear Thermometer 2. Equivalent legally marketed device: This product is similar in design and identical in function to the K01 1059/ INFARED EAR THERMOMETER, MODEL TH8 SERIES I RADIANT INNOVATION, INC. 3. Indications for Use (intended use): Th…	Radiant Innovation, Inc.	2001	—

Also cleared against K011059: 7 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K111703	Infrared Ear Therometer	Fudakang Industrial Co., Ltd.	2012	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, K111703 (Fudakang Industrial Co., Ltd., 2012) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K011059.

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?

Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081788 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081788: Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081788

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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