# K093244: Unique Temp Warming Blankets, Model 8001140XXX

- Pathway: 510(k) (Traditional)
- Applicant: Geratherm Medical AG
- Decided: Oct 19, 2010 after 369 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: 3 generations back to K991684 (2000). 4 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052392: Hot Dog Patient Warming System, Augustine Biomedical & Design, LLC (2006) Summary page 1.

## Most influential descendants
- 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
- K152258: T3 Software (2016), 16 descendants of its own
- K163065: T3 Software (2017), 15 descendants of its own

## Indications for use
Geratherm UniqueTemp0 is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Source page: https://510kreport.com/device/K093244
Methodology: https://510kreport.com/methodology