# K232508: Barrier EasyWarm Active Self-Warming Blanket

- Pathway: 510(k) (Special)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Sep 15, 2023 after 28 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: 5 generations back to K991684 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132048: Barrier Easywarm Active Self-Warming Blanket, Molnlycke Health Care Us, LLC (2013) Summary page 4.

## Indications for use
The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

Source page: https://510kreport.com/device/K232508
Methodology: https://510kreport.com/methodology