510(k) · Cleared

Cleared

Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series

K030324510(k) SpecialCleared Feb 27, 200327-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

Radiant Innovation, Inc. · FLL Continuous Measurement Thermometer

Cleared on Feb 27, 2003 as substantially equivalent to K011059 (Radiant Innovation, Inc., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001. 21 later devices descend from it.

Decided: Feb 27, 2003
Review: 27 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011059 (2001). 21 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
This deviceK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
Descendant · cites it directly · 20 of its ownK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
Descendant · 2 generations on · 19 of its ownK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
Descendant · 3 generations on · 18 of its ownK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
Descendant · 4 generations on · 14 of its ownK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
Descendant · 5 generations on · 8 of its ownK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2004high 3 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 21 · See all

K040377Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004 · cites it directly20descendants
K051269Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005 · 2 generations on19descendants
K063185Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006 · 3 generations on18descendants
K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017 · 4 generations on14descendants
K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019 · 5 generations on8descendants

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)	K030324	Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series	Radiant Innovation, Inc.	2003	—
+1	K040377	Rii Infrared Ear Thermometer, Models Thxxn Series	Radiant Innovation, Inc.	2004	—
+2	K051269	Rii Infrared Ear Thermometer, Models TH00XY Series	Radiant Innovation, Inc.	2005	—
+3	K063185	Rii Infrared Ear Thermometer, Models TH5XY Series	Radiant Innovation, Inc.	2006	—
+4	K162083	RII Multi-function Infrared Thermometer, Model TH52Z	Radiant Innovation, Inc.	2017	—
+5	K191570	Infrared Thermometer Model MD-H30	Guangzhou Berrcom Medical Device Co., Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2010	2	0
2017	1	0
2018	2	0
2019	2	0
2020	2	0
2021	3	0
2022	3	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K030324, 2001–2025Source: 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
*	K011059	Infared Ear Thermometer, Model TH8 Series	Radiant Innovation, Inc.	2001	—

Also cleared against K011059: 7 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K040377	Rii Infrared Ear Thermometer, Models Thxxn Series	Radiant Innovation, Inc.	2004	20

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, K040377 (Radiant Innovation, Inc., 2004) has gone furthest, with 20 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.

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 device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030324: Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030324

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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