Cleared Special

K171234 - Mistral-Air Warming Unit

K171234 is an FDA 510(k) clearance for Mistral-Air Warming Unit, manufactured by The Surgical Company International BV (As the 37company). The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Special 510(k) pathway after a 29-day FDA review.

K171234 · The Surgical Company International BV (As the 37company) · Cardiovascular device
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May 2017
Decision
29d
Days
Class 2
Risk

K171234 is an FDA 510(k) clearance for the Mistral-Air Warming Unit. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by The Surgical Company International BV (As the 37company) (Amersfoort, NL). The FDA issued a Cleared decision on May 26, 2017 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 BV (As the 37company) devices

FDA 510(k) Submission Details - K171234

510(k) Number K171234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2017
Decision Date May 26, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 64
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K171234.
Level 1 Convective Warmer
K181699 · Smiths Medical Asd, Inc. · Jul 2018
The IQoolTM Warm System
K180375 · Braincool AB · May 2018
3M Bair Hugger Model 675 Total Temperature Management System
K171373 · 3M Company · Oct 2017
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · Molnlycke Health Care Us, LLC · Nov 2013
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
K131361 · Covidien · Jul 2013
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · Covidien · Apr 2013