# K021473: Bair Hugger Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Medical, Inc.
- Decided: Jul 9, 2002 after 62 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 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) Augustine Medical, Bair Hugger Model 600 Hyper/hypothermia unit used with Bair Hugger blankets: named in the summary without a submission number
- (no number) Seabrook Medical Systems, Tropi-Cool Hyperhypothermia unit used with Temp-pad blankets: named in the summary without a submission number

## Most influential descendants
- K041686: Bair Hugger Temperature Management System (2004), 7 descendants of its own
- K162679: IOB Temperature Management System (2017), 6 descendants of its own
- K053645: Modification to:Bair Hugger Temperature Management Systems (2006), 6 descendants of its own
- K190221: IOB Warming Blankets (2019), 4 descendants of its own
- K060865: Bair Paws Temperature Management System Model 850 (2006), 4 descendants of its own

## Indications for use
The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.

Source page: https://510kreport.com/device/K021473
Methodology: https://510kreport.com/methodology