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510(k) K261437

Mistral-Air® Warming System by The Surgical Company International B.V., doing business as TSC Life — Product Code DWJ

K261437 is an FDA 510(k) premarket notification submitted by The Surgical Company International B.V., doing business as TSC Life for the device "Mistral-Air® Warming System". The FDA issued a decision of Substantially Equivalent on August 7, 2026. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2026
Date Received
April 30, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

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).

Other clearances for product code DWJ

  • K262089 — Disposable Warming Blanket (August 21, 2026)
  • K260278 — ThermAffyx(TM) Patient Safety System (July 8, 2026)
  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K252861 — Warming System (April 7, 2026)
  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K242964 — Celsi Warmer (June 20, 2025)
  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)

FDA data resources