510(k) Report

510(k) · Cleared

Cleared

Braun No Touch + Forehead NTF3000 Thermometer

K163516510(k) SpecialCleared Apr 21, 2017127-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 Helen of Troy Company · FLL Continuous Measurement Thermometer

Cleared on Apr 21, 2017 as substantially equivalent to K134043 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2014) after a 127-day review. Its family tree reaches back 4 generations to 2001. 16 later devices descend from it.

Decided
Apr 21, 2017
Review
127 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K011291 (2001). 16 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2020: 5 descendants cleared2021: 5 descendants cleared2018: 2 descendants cleared2023: 2 descendants cleared2019: 1 descendant cleared2022: 1 descendant clearedK011291 · Temporalscanner Thermometer, Sensortouch · Exergen Corp. · 2001K033790 · Thermofocus 0800, 0900, 01500 and 0700 Series · Tecnimed S.R.L. · 2004K081160 · Avita Radar Thermo IR Thermometer, NT1 Series · Avita Corporation · 2008K134043 · NO Touch+Forehead NTF 3000 Thermometer · Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014200020052010201520202025
Descendants, by generation 1 generation forward: 10 descendants2 generations forward: 6 descendants K134043 · NO Touch+Forehead NTF 3000 Thermometer · Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014K081160 · Avita Radar Thermo IR Thermometer, NT1 Series · Avita Corporation · 2008K033790 · Thermofocus 0800, 0900, 01500 and 0700 Series · Tecnimed S.R.L. · 2004K011291 · Temporalscanner Thermometer, Sensortouch · Exergen Corp. · 20010
  1. Root · 4 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
  2. 3 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
  3. 2 generations backK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
  4. 1 generation backK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
  5. This deviceK163516 Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017
  6. Descendant · cites it directly · 3 of its ownK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019
  7. Descendant · cites it directly · 1 of its ownK202483 MyHomeDocMyhomedoc, Ltd. · 2021
  8. Descendant · cites it directly · 1 of its ownK201864 YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020
  9. Descendant · cites it directly · 1 of its ownK181242 Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
  10. Descendant · 2 generations on · 0 of its ownK223785 N9+Nonagon, Ltd. · 2023

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2018: 22019: 12020: 52021: 52022: 12023: 2
2018high 5 (2020) · low 0 (2024)2026

Most influential descendants

Showing 5 of 16 · See all
  • K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019 · cites it directly3descendants
  • K202483MyHomeDocMyhomedoc, Ltd. · 2021 · cites it directly1descendant
  • K201864YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020 · cites it directly1descendant
  • K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2018 · cites it directly1descendant
  • K223785N9+Nonagon, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011291Temporalscanner Thermometer, SensortouchExergen Corp.2001—
−3K033790Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.2004—
−2K081160Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation2008—
−1K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc)2014—
0 (this device)K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company2017—
+1K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd.2019—
+1K202483MyHomeDocMyhomedoc, Ltd.2021—
+1K201864YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2020—
+1K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company2018—
+2K223785N9+Nonagon, Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
201910
202050
202150
202210
202320
FIG. 1 — Lineage of K163516, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K134043NO Touch+Forehead NTF 3000 Thermometer
Summary page 4
…Clinical, Electronic Regulation Number: 21CFR 880.2910 Regulatory Class: II Product Code: FLL III. PREDICATE DEVICE NTF3000 No Touch + Forehead Infrared Thermometer, K134043 IV. DEVICE DESCRIPTION The Braun No Touch + Forehead NTF3000 Thermometer is a hand-held, battery powered, infrared thermomet…
Kaz USA, Inc (A Subsidiaryof Kaz Inc)2014—

Also cleared against K134043: 7 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd.20193
K202483MyHomeDocMyhomedoc, Ltd.20211
K201864YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20201
K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20181
K220657Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)Zhejiang Rongsheng Industrial Co., Ltd.20230
K202296Infrared Forehead Thermometer, Model BSX976Shenzhen Bsx Technology Electronics Co., Ltd.20210
K200159Non-contact Infrared Body Thermometer, model:HTD8823USHetaida Technology Co., Ltd.20210
K200781Infrared Body ThermometerHeitaida Technology Co., Ltd.20200
K193213Vicks VNT200 No Touch Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20200
K181015Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20180

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 16 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K182597 (Shenzhen Pango Electronic Co., Ltd., 2019) has gone furthest, with 3 descendants of its own.
  • 7 other devices also cite its predicate K134043.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · FLL

6in 2025

2007: 152008: 142009: 132010: 242011: 202012: 172013: 142014: 72015: 32016: 222017: 162018: 352019: 222020: 212021: 432022: 242023: 172024: 132025: 62026 (partial year): 2
2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007: 81 days median2008: 59 days median2009: 84 days median2010: 88 days median2011: 113 days median2012: 126 days median2013: 149 days median2014: 199 days median2015: 270 days median2016: 157 days median2017: 174 days median2018: 209 days median2019: 198 days median2020: 194 days median2021: 218 days median2022: 218 days median2023: 295 days median2024: 223 days median2025: 131 days median
2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2011: 12015: 12017: 22018: 12019: 52025: 12026 (partial year): 1
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

2007: 42008: 132009: 92010: 92011: 182012: 262013: 162014: 542015: 532016: 582017: 1182018: 512019: 522020: 532021: 1152022: 1422023: 1012024: 1182025: 73
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007158104
20081459013
2009138409
2010248809
201120113118
201217126026
201314149016
20147199054
20153270153
201622157058
2017161742118
201835209151
201922198552
202021194053
2021432180115
2022242180142
2023172950101
2024132230118
20256131173
20262—1—

What is it indicated for?

The Braun No Touch + Forehead NTF3000 Thermometer 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 center of the forehead as the measurement site on people of all ages.

Indications for use as stated in the FDA summary.

Also cleared against K134043

7 other devices cite the same predicate.

  • K191668Infrared Forehead Thermometer (Model IR-FT)Comper Chuangxiang (Beijing) Technology Co., Ltd. · 2019
  • K190242Tyto ThermometerTyto Care, Ltd. · 2019
  • K180207Non-contact Infrared ThermometerAlicn Medical (Shenzhen), Inc. · 2018
  • K170662Non Contact Infrared Forehead ThermometerIntrinity Global Limited · 2017
  • K162509Infrared Non-contact Thermometer, Model ACT8100Easywell Biomedicals, Inc. · 2017
  • K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. · 2016

More from Kaz USA, Inc., A Helen of Troy Company

8 FDA decisions under this applicant name. See the company

  • K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022
  • K193213Vicks VNT200 No Touch Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2020
  • K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
  • K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
  • K181015Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2018

Recent decisions in FLL

The FLL category page

  • K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature…Unimed Medical Supplies, Inc. · 2026
  • K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026
  • K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd. · 2025
  • K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd. · 2025
  • K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025

https://510kreport.com/device/K163516 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163516: Braun No Touch + Forehead NTF3000 Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163516

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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