# K210605: 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Apr 29, 2021 after 59 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.
No later device cites it as a predicate yet.
0 of 3 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 5.

## Indications for use
The 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is part of the 3M patient temperature management system ('the system') when used with Bair Hugger 700 series or 675 warming unit. The system, monitored and controlled by a trained clinician, is used perioperatively to prevent and treat hypothermia.

Source page: https://510kreport.com/device/K210605
Methodology: https://510kreport.com/methodology