# K023934: Rapid Thermal Exchange System

- Pathway: 510(k) (Traditional)
- Applicant: Avacore Technologies, Inc.
- Decided: Jan 23, 2003 after 58 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 K970376 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014210: Palmo Thermoregulation Interface Accessory, Avacore Technologies, Inc. (2002)

## Indications for use
The Rapid Thermal Exchange System is designed to noninvasively lower or raise a patient’s temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to a distal appendage.

Source page: https://510kreport.com/device/K023934
Methodology: https://510kreport.com/methodology