510(k) · Cleared
Recalled · Class II · 2024Braun Thermoscan PRO 6000 Ear Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · FLL Continuous Measurement Thermometer
Cleared on Mar 1, 2016 as substantially equivalent to K103800 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2011) after a 160-day review. Its family tree reaches back 3 generations to 2003. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 1, 2016
- Review
- 160 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K031928 (2003). 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
- 2 generations backK101747 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010
- 1 generation backK103800 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2011
- This deviceK152748 Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · 2016
- Descendant · cites it directly · 3 of its ownK182597 Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK203583 YUWELL infrared ear thermometer: YHT101, YHT200Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK250470 Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear…Shenzhen AOJ Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250878 YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK212346 Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615…Shenzhen Pango Medical Electronics Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd. · 2019 · cites it directly3descendants
- K203583YUWELL infrared ear thermometer: YHT101, YHT200Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2021 · cites it directly1descendant
- K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025 · cites it directly0descendants
- K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618Shenzhen Pango Medical Electronics Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun… | Braun GmbH | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | 2016 | — |
| +1 | K182597 | Infrared thermometer | Shenzhen Pango Electronic Co., Ltd. | 2019 | — |
| +1 | K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2021 | — |
| +2 | K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer… | Shenzhen AOJ Medical Technology Co., Ltd. | 2025 | — |
| +1 | K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer… | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025 | — |
| +2 | K212346 | Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 | Shenzhen Pango Medical Electronics Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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.
What descends from it? (8)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 13, 2024 | Class II | Z-2339-2024 | Process control | The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). |
| Jul 20, 2021 | Class II | Z-2482-2021 | Labeling design | If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K182597 (Shenzhen Pango Electronic Co., Ltd., 2019) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K103800.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152748: Braun Thermoscan PRO 6000 Ear Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152748
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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