# K960167: System, Thermal Regulating 74-DWJ

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Medical, Inc.
- Decided: Jun 17, 1996 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
No predicates in its family tree.
19 later devices descend from it; 4 cite it directly.
0 of 20 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) Bair Hugger® Patient Warming System, Model 500 Warming Unit: named in the summary without a submission number

## Most influential descendants
- K041686: Bair Hugger Temperature Management System (2004), 7 descendants of its own
- K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 (2009), 6 descendants of its own
- K053645: Modification to:Bair Hugger Temperature Management Systems (2006), 6 descendants of its own
- K094056: Hotdog Multi Function Controller (2010), 4 descendants of its own
- K060865: Bair Paws Temperature Management System Model 850 (2006), 4 descendants of its own

Source page: https://510kreport.com/device/K960167
Methodology: https://510kreport.com/methodology