# K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Medical, Inc.
- Decided: Sep 6, 2000 after 149 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
57 later devices descend from it; 10 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052392: Hot Dog Patient Warming System (2006), 35 descendants of its own
- K093244: Unique Temp Warming Blankets, Model 8001140XXX (2010), 20 descendants of its own
- K123002: Vital Sync System (2013), 19 descendants of its own
- K142732: T3 Software (2015), 18 descendants of its own
- K151715: T3 Software (2015), 17 descendants of its own

## Recalls of this device
- Mar 11, 2005 · Not classified · Z-0855-05: Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging 

Source page: https://510kreport.com/device/K001149
Methodology: https://510kreport.com/methodology