SIROCCO THERMAL REGULATING SYSTEM— 510(k) K102856

Name: FDA 510(k) clearance K102856
Creator: U.S. Food and Drug Administration
Published: 2011-06-30

Substantially Equivalent

Galmaz Biotech S.L.

FDA 510(k) clearance K102856 for SIROCCO THERMAL REGULATING SYSTEM, Substantially Equivalent on 2011-06-30. Applicant: Galmaz Biotech S.L.. Device class: 2.

Clearance details

Applicant: Galmaz Biotech S.L.
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2010-09-29
Decision date: 2011-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

view all

K262089 — Disposable Warming Blanket2026-08-21
K261437 — Mistral-Air® Warming System2026-08-07
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16
K252861 — Warming System2026-04-07

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.