# K152748: Braun Thermoscan PRO 6000 Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
- Decided: Mar 1, 2016 after 160 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031928 (2003). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103800: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear Thermometers, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2011) Summary page 5.

## Most influential descendants
- K182597: Infrared thermometer (2019), 3 descendants of its own
- K203583: YUWELL infrared ear thermometer: YHT101, YHT200 (2021), 1 descendant of its own
- K250470: Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (2025), 0 descendants of its own
- K250878: YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (2025), 0 descendants of its own
- K212346: Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 (2022), 0 descendants of its own

## Recalls of this device
- Jun 13, 2024 · Class II · Z-2339-2024: The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K152748
Methodology: https://510kreport.com/methodology