Cleared Special

K261437 - Mistral-Air® Warming System

K261437 is an FDA 510(k) clearance for Mistral-Air Warming System, manufactured by The Surgical Company International B.V., doing business as TSC Life. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Special 510(k) pathway after a 99-day FDA review.

K261437 · The Surgical Company International B.V., doing business as TSC Life · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
99d
Days
Class 2
Risk

K261437 is an FDA 510(k) clearance for the Mistral-Air® Warming System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by The Surgical Company International B.V., doing business as TSC Life (Amsterdam, NL). The FDA issued a Cleared decision on August 7, 2026 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

FDA 510(k) Submission Details - K261437

510(k) Number K261437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2026
Decision Date August 07, 2026
Days to Decision 99 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition 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 Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 98
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K261437.
Disposable Warming Blanket
K262089 · Hangzhou Tappa Medical Technology Co., Ltd. · Aug 2026
ThermAffyx(TM) Patient Safety System
K260278 · Stihler Electronic GmbH · Jul 2026
Hot Pink Pad Warming System
K260903 · Xodus Medical, Inc. · Apr 2026
Warming System
K252861 · Hangzhou Tappa Medical Technology Co., Ltd. · Apr 2026
Arctic Sun Temperature Management System (Model 5000)
K251974 · Medivance, Inc. · Oct 2025
Celsi Warmer
K242964 · Hadleigh Health Technologies · Jun 2025