# K093694: Geratherm Uniqueresc

- Pathway: 510(k) (Traditional)
- Applicant: Geratherm Medical AG
- Decided: Sep 20, 2010 after 294 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 K051097 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051097: Geratherm Sos-Rescue Blanket, Rg Ent., Inc. (2006) Summary page 1.

## Indications for use
Geratherm UniqueResc is a thermal regulating system for adult patients in order to prevent hypothermia in preclinical settings or treatments on-site. It is intended for use while at the rescue scene, during patient transport by air or ground to a medical facility or e.g. during disaster operation in first aid tents. The device should be used by appropriately trained healthcare professionals.

Source page: https://510kreport.com/device/K093694
Methodology: https://510kreport.com/methodology