Cleared Traditional

K231211 - Medline ComfortTemp Patient Warming System

K231211 is an FDA 510(k) clearance for Medline ComfortTemp Patient Warming System, manufactured by Medline Industries, LP. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K231211

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.

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 98
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