510(k) · Cleared

Cleared

NO Touch+Forehead NTF 3000 Thermometer

K134043510(k) TraditionalCleared May 21, 2014141-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

Kaz USA, Inc (A Subsidiaryof Kaz Inc) · FLL Continuous Measurement Thermometer

Cleared on May 21, 2014 as substantially equivalent to K081160 (Avita Corporation, 2008) after a 141-day review. Its family tree reaches back 3 generations to 2001. 36 later devices descend from it.

Decided: May 21, 2014
Review: 141 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K011291 (2001). 36 later devices descend from it, 8 citing it directly.

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 deviceK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
Descendant · cites it directly · 16 of its ownK163516 Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017
Descendant · cites it directly · 10 of its ownK170662 Non Contact Infrared Forehead ThermometerIntrinity Global Limited · 2017
Descendant · 2 generations on · 4 of its ownK193253 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 2020
Descendant · 2 generations on · 3 of its ownK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019
Descendant · 2 generations on · 3 of its ownK180355 Advocate Non-Contact Infrared ThermometerBroadmaster Biotech, Corp. · 2019

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2016high 8 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 36 · See all

K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017 · cites it directly16descendants
K170662Non Contact Infrared Forehead ThermometerIntrinity Global Limited · 2017 · cites it directly10descendants
K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd. · 2020 · 2 generations on4descendants
K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019 · 2 generations on3descendants
K180355Advocate Non-Contact Infrared ThermometerBroadmaster Biotech, Corp. · 2019 · 2 generations on3descendants

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)	K134043	NO Touch+Forehead NTF 3000 Thermometer	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	2014	—
+1	K163516	Braun No Touch + Forehead NTF3000 Thermometer	Kaz USA, Inc., A Helen of Troy Company	2017	—
+1	K170662	Non Contact Infrared Forehead Thermometer	Intrinity Global Limited	2017	—
+2	K193253	Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503	Shenzhen Changkun Technology Co., Ltd.	2020	—
+2	K182597	Infrared thermometer	Shenzhen Pango Electronic Co., Ltd.	2019	—
+2	K180355	Advocate Non-Contact Infrared Thermometer	Broadmaster Biotech, Corp.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K134043, 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
*	K081160	Avita Radar Thermo IR Thermometer, NT1 Series Summary page 2 …Predicate Manufacturer Docket Safety 1V ProGrade Health No Touch Safety 1'0 (Avita) K081 160 Thermometer 5.0 Device Description: The No Touch+Forehead Thermometer ( Model NTF3000US) is a hand-hel…	Avita Corporation	2008	—
†	K031968	Cerabien ZR	Noritake Co., Inc.	2003	—
†	K101747	Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro…	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	2010	—
†	K103800	Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared…	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	2011	—

Also cleared against K081160: 1 other device →

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K163516	Braun No Touch + Forehead NTF3000 Thermometer	Kaz USA, Inc., A Helen of Troy Company	2017	16
K170662	Non Contact Infrared Forehead Thermometer	Intrinity Global Limited	2017	10
K191668	Infrared Forehead Thermometer (Model IR-FT)	Comper Chuangxiang (Beijing) Technology Co., Ltd.	2019	1
K190242	Tyto Thermometer	Tyto Care, Ltd.	2019	1
K160544	Withings Thermo (Model SCT01)	Withings	2016	1
K180207	Non-contact Infrared Thermometer	Alicn Medical (Shenzhen), Inc.	2018	0
K162509	Infrared Non-contact Thermometer, Model ACT8100	Easywell Biomedicals, Inc.	2017	0
K161735	Non-contact Forehead Thermometer	Shenzhen Dongdixin Technology Co., Ltd.	2016	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 13 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K163516 (Kaz USA, Inc., A Helen of Troy Company, 2017) has gone furthest, with 16 descendants of its own.
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. 2014, 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 No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical thermometer intended for the

intermittent determination of human body temperature in a touch and no touch mode on the centre of the forehead as the measurement

site on people of all ages.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K134043 · printed Nov 6, 2026

Cite this page

510(k) Report. “K134043: NO Touch+Forehead NTF 3000 Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134043

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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