# K031728: Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket

- Pathway: 510(k) (Traditional)
- Applicant: Klimamed Technologie Medizingerate GmbH
- Decided: Oct 12, 2004 after 496 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 K011859 (2002). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011859: Klimamed Thermal Mat & Controller 95 and 55 Watts, Klimamed Technologie Medizingerate GmbH (2002)

## Most influential descendants
- K051419: Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 (2006), 9 descendants of its own
- K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 (2009), 6 descendants of its own
- K094056: Hotdog Multi Function Controller (2010), 4 descendants of its own
- K201779: HotDog Temperature Management Controller (2020), 3 descendants of its own
- K220941: HotDog Temperature Management System (2022), 2 descendants of its own

## Indications for use
The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. The device has heating capability, not cooling.

Source page: https://510kreport.com/device/K031728
Methodology: https://510kreport.com/methodology