# K963731: Tru-5000 Thermal Recovery Radiant Heating Unit

- Pathway: 510(k) (Traditional)
- Applicant: Enthermics Medical Systems, Inc.
- Decided: Apr 22, 1997 after 217 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 K873745 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873745: Bair Hugger (TM) - Patient Warming System, Augustine Medical, Inc. (1987) Summary page 2.
- K904690: Temp Marq (TM) Convective Warming System, Marquest Medical Products, Inc. (1991) Summary page 2.

## Indications for use
The use of the TRU-5000 is a physician prescribed therapy for surgically- or trauma-induced hypothermia, with the ultimate responsibility of the patients overall recovery falling on the physician.

Source page: https://510kreport.com/device/K963731
Methodology: https://510kreport.com/methodology