# K103800: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear Thermometers

- Pathway: 510(k) (Special)
- Applicant: Kaz USA, Inc (A Subsidiaryof Kaz Inc)
- Decided: Jan 26, 2011 after 29 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031928 (2003). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031928: Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment), Braun GmbH (2003) Summary page 4.
- K101747: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series, 6022790-Irt 4000 SE, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2010) Summary page 4.

## Most influential descendants
- K152748: Braun Thermoscan PRO 6000 Ear Thermometer (2016), 8 descendants of its own
- 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

## Indications for use
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 respectively. The probe cover is used as a sanitary barrier between the infra-red thermometer, and the ear canal.

Source page: https://510kreport.com/device/K103800
Methodology: https://510kreport.com/methodology