Cleared Traditional

FilteredFlo Warming Blankets

K232638 · Iob Medical, Inc. · Cardiovascular

Oct 2023

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K232638 is an FDA 510(k) clearance for the FilteredFlo Warming Blankets, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Iob Medical, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on October 24, 2023, 55 days after receiving the submission on August 30, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K232638 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2023
Decision Date	October 24, 2023
Days to Decision	55 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).