510(k) · Cleared

Cleared

Avita Radar Thermo IR Thermometer, Model NT 152

K092959510(k) SpecialCleared Nov 27, 200963-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

Avita Corporation · FLL Continuous Measurement Thermometer

Cleared on Nov 27, 2009 as substantially equivalent to K081160 (Avita Corporation, 2008) after a 63-day review. Its family tree reaches back 3 generations to 2001.

Decided: Nov 27, 2009
Review: 63 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K011291 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
2 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
1 generation backK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
This deviceK092959 Avita Radar Thermo IR Thermometer, Model NT 152Avita Corporation · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K011291	Temporalscanner Thermometer, Sensortouch	Exergen Corp.	2001	—
−2	K033790	Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2004	—
−1	K081160	Avita Radar Thermo IR Thermometer, NT1 Series	Avita Corporation	2008	—
0 (this device)	K092959	Avita Radar Thermo IR Thermometer, Model NT 152	Avita Corporation	2009	—

FIG. 1 — Lineage of K092959, 2001–2009Source: 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
*	K081160	Avita Radar Thermo IR Thermometer, NT1 Series Summary page 1 …Regulation Number: 21CFR 880.2910 4. Predicate Device: The predicate device is the AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES (K081160) marketed by AVITA CORPORATION. 5. Intended Use: The AViTA Radar Thermo IR Thermometer (Model no.…	Avita Corporation	2008	—

Also cleared against K081160: 1 other device →

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K081160.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 AViTA Radar Thermo IR Thermometer (Model no. NT 152) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092959 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092959: Avita Radar Thermo IR Thermometer, Model NT 152.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092959

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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