Mistral-Air® Warming System— 510(k) K261437

Name: FDA 510(k) clearance K261437
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Substantially Equivalent

The Surgical Company International B.V., doing business as TSC Life

FDA 510(k) clearance K261437 for Mistral-Air® Warming System, Substantially Equivalent on 2026-08-07. Applicant: The Surgical Company International B.V., doing business as TSC Life. Device class: 2.

Clearance details

Applicant: The Surgical Company International B.V., doing business as TSC Life
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2026-04-30
Decision date: 2026-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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K262089 — Disposable Warming Blanket2026-08-21
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16
K252861 — Warming System2026-04-07
K251974 — Arctic Sun Temperature Management System (Model 5000)2025-10-24

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.