# K062794: PRN Thermalcare, Model 3000

- Pathway: 510(k) (Traditional)
- Applicant: American Healthcare Products, Inc.
- Decided: Dec 7, 2006 after 80 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 K002577 (2000). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 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.
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000) Summary page 1.
- K033021: Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads, Kimberly-Clark Corp. (2003) Summary page 1.

## Most influential descendants
- K113705: Pintler Patient Warming System (2012), 0 descendants of its own
- K080763: Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT (2008), 0 descendants of its own

## Indications for use
The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 lbs./225k

Source page: https://510kreport.com/device/K062794
Methodology: https://510kreport.com/methodology