# K113705: Pintler Patient Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Pintler Medical
- Decided: Aug 31, 2012 after 259 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002577 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062794: PRN Thermalcare, Model 3000, American Healthcare Products, Inc. (2006) Summary page 1.

## Recalls of this device
- Apr 20, 2018 · Class II · Z-1139-2019: Malfunction warming pad.

## Indications for use
The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.

Source page: https://510kreport.com/device/K113705
Methodology: https://510kreport.com/methodology