# K051419: Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1

- Pathway: 510(k) (Traditional)
- Applicant: Inditherm Medical
- Decided: Apr 27, 2006 after 330 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: 2 generations back to K011859 (2002). 2 ancestors in all.
9 later devices descend from it; 3 cite 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) Summary page 1.
- K031728: Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket, Klimamed Technologie Medizingerate GmbH (2004) Summary page 1.

## Most influential descendants
- 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
- K230866: HotDog Warming Mattress + Return Electrode (2023), 1 descendant of its own

## Indications for use
Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department, the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. The mattress includes a pressure-relieving pad.

Source page: https://510kreport.com/device/K051419
Methodology: https://510kreport.com/methodology