510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K261437Substantially Equivalent

Mistral-Air® Warming System

The Surgical Company International B.V., doing business as TSC Life, Amsterdam, NL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261437 is the FDA 510(k) clearance record for Mistral-Air® Warming System, a class II device, cleared for The Surgical Company International B.V., doing business as TSC Life on under FDA product code DWJ (System, Thermal Regulating). FDA's definition for product code DWJ reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list one 510(k) clearance for The Surgical Company International B.V., doing business as TSC Life. As of , FDA records show no recalls naming K261437.

Clearance record

Decision date
Received
(99 days to decision)
Product code
DWJ System, Thermal Regulating
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
The Surgical Company International B.V., doing business as TSC Life Paalbergweg 3, Amsterdam, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWJ

Trailing 12 months
5 clearances under product code DWJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20262
September 20260
October 20260