510(k) · Cleared
ClearedBraun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series, 6022790-Irt 4000 SE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaz USA, Inc (A Subsidiaryof Kaz Inc) · FLL Continuous Measurement Thermometer
Cleared on Aug 4, 2010 as substantially equivalent to K031928 (Braun GmbH, 2003) after a 43-day review. Its family tree reaches back 1 generation to 2003. 14 later devices descend from it.
- Decided
- Aug 4, 2010
- Review
- 43 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031928 (2003). 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
- This deviceK101747 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010
- 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
- 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
- Descendant · 3 generations on · 3 of its ownK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK203583 YUWELL infrared ear thermometer: YHT101, YHT200Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK250470 Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear…Shenzhen AOJ Medical Technology Co., Ltd. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- 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
- K203583YUWELL infrared ear thermometer: YHT101, YHT200Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2021 · 3 generations on1descendant
- K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun… | Braun GmbH | 2003 | — |
| 0 (this device) | K101747 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model… | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2010 | — |
| +1 | K103800 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical… | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2011 | — |
| +2 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | 2016 | 2 |
| +3 | K182597 | Infrared thermometer | Shenzhen Pango Electronic Co., Ltd. | 2019 | — |
| +3 | K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2021 | — |
| +4 | K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer… | Shenzhen AOJ Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt…Summary page 3…perating principle of the Braun Thermoscan® PRO 4000 series and Braun Thermoscan® IRT 4000 series Clinical Infrared Ear Thermometers or that of the probe covers (K03 1928). The probe cover is a plastic cover that is used as a sanitary barrier between the infra red thermometer and the ear ca… | 2003 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 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 Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use/professional use environment.
The probe cover is used as a sanitary barrier between the infrared thermometer and the ear canal.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101747: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series, 6022790-Irt 4000 SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101747
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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