Cleared Traditional

K231211 - Medline ComfortTemp Patient Warming System

K231211 is the FDA 510(k) clearance for Medline ComfortTemp Patient Warming System by Medline Industries, LP. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

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.

View all Medline Industries, LP devices

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.

Regulatory Peers - DWJ System, Thermal Regulating

All 41
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K231211.
Arctic Sun Stat Temperature Management System
K243942 · Medivance, Inc. · Apr 2025
HotDog Warming Mattress + Return Electrode
K232627 · Augustine Temperature Management, LLC · Apr 2024
Cocoon Convective Warming System, Model CWS7000
K232502 · Care Essentials Pty, Ltd. · Feb 2024
FilteredFlo Warming Blankets
K232638 · Iob Medical, Inc. · Oct 2023
The IQoolTM System
K232844 · Braincool AB · Oct 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · Molnlycke Health Care Us, LLC · Sep 2023