# K203085: NOVA Patient Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Encompass Group, LLC
- Decided: Nov 12, 2020 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The NOVA Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. It should be used in circumstances in which patients may not maintain a state of normothermia. It is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors. Not for use in home health care environment

Source page: https://510kreport.com/device/K203085
Methodology: https://510kreport.com/methodology