Mistral-Air Warming Unit— 510(k) K171234

Name: FDA 510(k) clearance K171234
Creator: U.S. Food and Drug Administration
Published: 2017-05-26

Substantially Equivalent

The Surgical Company International BV (As the 37company)

FDA 510(k) clearance K171234 for Mistral-Air Warming Unit, Substantially Equivalent on 2017-05-26. Applicant: The Surgical Company International BV (As the 37company). Device class: 2.

Clearance details

Applicant: The Surgical Company International BV (As the 37company)
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2017-04-27
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Amersfoort, NL

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.