510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101705Substantially Equivalent

Mistral-Air Warming System

The Surgical Company International B.V., Beeldschermweg 6g, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101705 is the FDA 510(k) clearance record for MISTRAL-AIR WARMING SYSTEM, a class II device, cleared for The Surgical Company International B.V. 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 3 510(k) clearances for The Surgical Company International B.V., from to . As of , FDA records show one recall naming K101705.

Clearance record

Decision date
Received
(15 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. 3821 Ah Amersfoort, Beeldschermweg 6g, NL
510(k) summary
Summary PDF
Third party review
Yes

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