Cleared Traditional

Medline ComfortTemp Patient Warming System

K231211 · Medline Industries, LP · Cardiovascular

Dec 2023

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K231211 is an FDA 510(k) clearance for the Medline ComfortTemp Patient Warming System, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on December 1, 2023, 217 days after receiving the submission on April 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K231211 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — 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).