# K031928: Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment)

- Pathway: 510(k) (Abbreviated)
- Applicant: Braun GmbH
- Decided: Oct 24, 2003 after 123 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
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Braun Thermoscan IRT 3000 infrared ear thermometer (consumer): named in the summary without a submission number
- (no number) Braun Thermoscan PRO 3000 infrared ear thermometer (professional): named in the summary without a submission number

## Most influential descendants
- K101747: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series, 6022790-Irt 4000 SE (2010), 14 descendants of its own
- K103800: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear Thermometers (2011), 11 descendants of its own
- K152748: Braun Thermoscan PRO 6000 Ear Thermometer (2016), 8 descendants of its own
- K182597: Infrared thermometer (2019), 3 descendants of its own
- K082192: Infrared Ear Thermometer, Model ET-101A (2008), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K031928
Methodology: https://510kreport.com/methodology