# K171373: 3M Bair Hugger Model 675 Total Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 10, 2017 after 153 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: 1 generation back to K001149 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000) Summary page 4.

## Most influential descendants
- K210603: 3M Bair Hugger Temperature Management System (Model 675) (2021), 1 descendant of its own
- K231211: Medline ComfortTemp Patient Warming System (2023), 0 descendants of its own
- K210605: 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation (2021), 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 conditions 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/K171373
Methodology: https://510kreport.com/methodology