# K210603: 3M Bair Hugger Temperature Management System (Model 675)

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Mar 30, 2021 after 29 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- 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 K001149 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171373: 3M Bair Hugger Model 675 Total Temperature Management System, 3M Company (2017) Summary page 4.

## Most influential descendants
- K231211: Medline ComfortTemp Patient Warming System (2023), 0 descendants of its own

## Indications for use
The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition the temperature management system can be used to provide patient thermal comfort when continuations exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

Source page: https://510kreport.com/device/K210603
Methodology: https://510kreport.com/methodology