Cleared Traditional

K231211 - Medline ComfortTemp Patient Warming System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231211 · Medline Industries, LP · Cardiovascular device

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Dec 2023

Decision

217d

Days

Class 2

Risk

K231211 is an FDA 510(k) clearance for the Medline ComfortTemp Patient Warming System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on December 1, 2023 after a review of 217 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number	K231211 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 28, 2023
Decision Date	December 01, 2023
Days to Decision	217 days
Submission Type	Traditional
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

92d slower than avg

Panel avg: 125d · This submission: 217d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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.