# K102856: Sirocco Thermal Regulating System

- Pathway: 510(k) (Traditional)
- Applicant: Galmaz Biotech S.L.
- Decided: Jun 30, 2011 after 274 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 K960167 (1996). 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)
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000)
- K960167: System, Thermal Regulating 74-DWJ, Augustine Medical, Inc. (1996) Summary page 1.

## Indications for use
The Galmaz Biotech® SIROCCOTM Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Bietech® SIROCCOTM Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

Source page: https://510kreport.com/device/K102856
Methodology: https://510kreport.com/methodology