# K014210: Palmo Thermoregulation Interface Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Avacore Technologies, Inc.
- Decided: Aug 16, 2002 after 238 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: 1 generation back to K970376 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970376: Ptca Guidewire, Lake Region Mfg., Inc. (1997) Summary page 1.
- (no number) Cincinnati Subzero Blanketrol II Hyper-Hypothermia System: named in the summary without a submission number

## Most influential descendants
- K023934: Rapid Thermal Exchange System (2003), 0 descendants of its own

## Indications for use
The Palmo Thermoregulation Interface Accessory is designed to noninvasively lower or raise a patient’s temperature andor maintain a desired patient temperature. This is accomplished with local application of negative pressure and heatingcooling to a distal appendage.

Source page: https://510kreport.com/device/K014210
Methodology: https://510kreport.com/methodology