# K991684: Chillbuster Portable Electric Blanket System, Model 8001

- Pathway: 510(k) (Traditional)
- Applicant: Thermogear, Inc.
- Decided: Mar 1, 2000 after 289 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.
41 later devices descend from it; 4 cite it directly.
0 of 42 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) Life-Air 1000® Hypothermic Therapy System: named in the summary without a submission number

## Most influential descendants
- K022903: Chillbuster (2002), 36 descendants of its own
- 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

## Indications for use
The ChillBuster® Model 8001 Portable Electric Blanket System has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.

Source page: https://510kreport.com/device/K991684
Methodology: https://510kreport.com/methodology