Cleared Special

K232508 - Barrier EasyWarm Active Self-Warming Blanket (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232508 · Molnlycke Health Care Us, LLC · Cardiovascular device

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Sep 2023

Decision

28d

Days

Class 2

Risk

K232508 is an FDA 510(k) clearance for the Barrier EasyWarm Active Self-Warming Blanket. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Molnlycke Health Care Us, LLC (Peachtree Corners, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 28 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 Molnlycke Health Care Us, LLC devices

Submission Details

510(k) Number	K232508 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 2023
Decision Date	September 15, 2023
Days to Decision	28 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

97d faster than avg

Panel avg: 125d · This submission: 28d

Pathway characteristics

Modification to existing cleared device.

Device Classification

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.