# K011859: Klimamed Thermal Mat & Controller 95 and 55 Watts

- Pathway: 510(k) (Traditional)
- Applicant: Klimamed Technologie Medizingerate GmbH
- Decided: May 1, 2002 after 321 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.
13 later devices descend from it; 4 cite it directly.
0 of 14 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) Allon 2001: named in the summary without a submission number

## Most influential descendants
- K031728: Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket (2004), 10 descendants of its own
- 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

## Indications for use
The device is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain 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

Source page: https://510kreport.com/device/K011859
Methodology: https://510kreport.com/methodology