510(k) · Cleared

Cleared

Avita Radar Thermo IR Thermometer, NT1 Series

K081160510(k) TraditionalCleared Jun 24, 200862-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 Jun 24, 2008 as substantially equivalent to K033790 (Tecnimed S.R.L., 2004) after a 62-day review. Its family tree reaches back 2 generations to 2001. 38 later devices descend from it.

Decided: Jun 24, 2008
Review: 62 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K011291 (2001). 38 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
1 generation backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
This deviceK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
Descendant · cites it directly · 36 of its ownK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
Descendant · 2 generations on · 16 of its ownK163516 Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017
Descendant · 2 generations on · 10 of its ownK170662 Non Contact Infrared Forehead ThermometerIntrinity Global Limited · 2017
Descendant · 3 generations on · 4 of its ownK193253 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 2020
Descendant · 3 generations on · 3 of its ownK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2009high 8 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 38 · See all

K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014 · cites it directly36descendants
K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017 · 2 generations on16descendants
K170662Non Contact Infrared Forehead ThermometerIntrinity Global Limited · 2017 · 2 generations on10descendants
K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 2020 · 3 generations on4descendants
K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K011291	Temporalscanner Thermometer, Sensortouch	Exergen Corp.	2001	—
−1	K033790	Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2004	—
0 (this device)	K081160	Avita Radar Thermo IR Thermometer, NT1 Series	Avita Corporation	2008	—
+1	K134043	NO Touch+Forehead NTF 3000 Thermometer	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	2014	—
+2	K163516	Braun No Touch + Forehead NTF3000 Thermometer	Kaz USA, Inc., A Helen of Troy Company	2017	—
+2	K170662	Non Contact Infrared Forehead Thermometer	Intrinity Global Limited	2017	—
+3	K193253	Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503	Shenzhen Changkun Technology Co., Ltd.	2020	—
+3	K182597	Infrared thermometer	Shenzhen Pango Electronic Co., Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0
2016	2	0
2017	3	0
2018	3	0
2019	5	0
2020	7	0
2021	8	0
2022	4	0
2023	2	0
2025	2	0

FIG. 1 — Lineage of K081160, 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

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
*	K033790	Thermofocus 0800, 0900, 01500 and 0700 Series Summary page 1 …Regulation Number: 21CFR 880.2910 4. Predicate Device: The predicate device is the Thermofocus 01500 Series Thermometer (K033790) marketed by TECNIMED SR.L.. 5. Intended Use: AViTA Radar Thermo NTI Series IR Forehead Thermom…	Tecnimed S.R.L.	2004	—

Also cleared against K033790: 1 other device →

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K134043	NO Touch+Forehead NTF 3000 Thermometer	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	2014	36
K092959	Avita Radar Thermo IR Thermometer, Model NT 152	Avita Corporation	2009	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?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K134043 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2014) has gone furthest, with 36 descendants of its own.
1 other device also cites its predicate K033790.

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 device 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/K081160 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081160: Avita Radar Thermo IR Thermometer, NT1 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081160

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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