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) Official FDA 510(k) Summary (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.

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 161
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K261437.
Arctic Sun™ Neonatal ArcticGel™ Pad
K263587 · Medivance, Inc. · Oct 2026
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
K261437 · Mistral-Air® Warming System
Download PDF FDA Summary The Surgical Company …