510(k) Report

510(k) · Cleared

Cleared

Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment)

K031928510(k) AbbreviatedCleared Oct 24, 2003123-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

Braun GmbH · FLL Continuous Measurement Thermometer

Cleared on Oct 24, 2003 after a 123-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.

Decided
Oct 24, 2003
Review
123 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

20 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2010: 2 descendants cleared2016: 2 descendants cleared2021: 3 descendants cleared2024: 1 descendant cleared2022: 2 descendants cleared2012: 1 descendant cleared2020: 2 descendants cleared2019: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
  2. Descendant · cites it directly · 14 of its ownK101747 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010
  3. Descendant · cites it directly · 11 of its ownK103800 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2011
  4. Descendant · 2 generations on · 8 of its ownK152748 Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · 2016 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019
  6. Descendant · cites it directly · 2 of its ownK082192 Infrared Ear Thermometer, Model ET-101ASejoy Electronics & Instruments Co., Ltd. · 2008

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22011: 12012: 12016: 22018: 12019: 12020: 22021: 32022: 22024: 12025: 2
2008high 3 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 20 · See all
  • K101747Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010 · cites it directly14descendants
  • K103800Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2011 · cites it directly11descendants
  • K152748Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · 2016 · 2 generations on8descendants
  • K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019 · 3 generations on3descendants
  • K082192Infrared Ear Thermometer, Model ET-101ASejoy Electronics & Instruments Co., Ltd. · 2008 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031928Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun…Braun GmbH2003—
+1K101747Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model…Kaz USA, Inc (A Subsidiaryof Kaz Inc)2010—
+1K103800Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical…Kaz USA, Inc (A Subsidiaryof Kaz Inc)2011—
+2K152748Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc)20162
+3K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd.2019—
+1K082192Infrared Ear Thermometer, Model ET-101ASejoy Electronics & Instruments Co., Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201110
201210
201620
201810
201910
202020
202130
202220
202410
202520
FIG. 1 — Lineage of K031928, 2003–2025Source: 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? (2)

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
*—Braun Thermoscan IRT 3000 infrared ear thermometer (consumer)
Named without a submission number
—
*—Braun Thermoscan PRO 3000 infrared ear thermometer (professional)
Named without a submission number
—

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K101747Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro…Kaz USA, Inc (A Subsidiaryof Kaz Inc)201014
K103800Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared…Kaz USA, Inc (A Subsidiaryof Kaz Inc)201111
K082192Infrared Ear Thermometer, Model ET-101ASejoy Electronics & Instruments Co., Ltd.20082
K090031Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear…Actherm, Inc.20091

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?

  • Of its descendants, K101747 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2010) has gone furthest, with 14 descendants of its own.

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

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 Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment.

The Braun Thermoscan IRT 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.

Indications for use as stated in the FDA summary.

More from Braun GmbH

7 FDA decisions under this applicant name. See the company

  • K061351Oral-B Sonic CompleteBraun GmbH · 2006
  • K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006
  • K060006Braun Thermoscan Irt 2000 Infrared Ear ThermometerBraun GmbH · 2006
  • K012035Braun Precision Sensor Pro, Model BP 2590Braun GmbH · 2001
  • K003732Braun Precision Sensor, Model BP 2000 SeriesBraun GmbH · 2001

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/K031928 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031928: Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031928

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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