# K231211: Medline ComfortTemp Patient Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Dec 1, 2023 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: 3 generations back to K001149 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210603: 3M Bair Hugger Temperature Management System (Model 675), 3M Company (2021) Summary page 4.

## Indications for use
The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

Source page: https://510kreport.com/device/K231211
Methodology: https://510kreport.com/methodology