# K041686: Bair Hugger Temperature Management System

- Pathway: 510(k) (Special)
- Applicant: Arizant Healthcare, Inc.
- Decided: Jun 30, 2004 after 8 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 K873745 (1987). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021473: Bair Hugger Temperature Management System, Augustine Medical, Inc. (2002) Summary page 1.
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000)
- K960167: System, Thermal Regulating 74-DWJ, Augustine Medical, Inc. (1996) Summary page 1.
- K903360: Bair Hugger (R) Patient Warming System-Modification, Augustine Medical, Inc. (1990) Summary page 1.
- K873745: Bair Hugger (TM) - Patient Warming System, Augustine Medical, Inc. (1987) Summary page 1.

## Most influential descendants
- K053645: Modification to:Bair Hugger Temperature Management Systems (2006), 6 descendants of its own
- K060865: Bair Paws Temperature Management System Model 850 (2006), 4 descendants of its own
- K083336: Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1 Snuggle Warm Left Lateral (2009), 2 descendants of its own
- K141686: Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body (2014), 1 descendant of its own
- K232502: Cocoon Convective Warming System, Model CWS7000 (2024), 0 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/K041686
Methodology: https://510kreport.com/methodology