Cleared Traditional

IOB Warming Blankets

K221669 · Iob Medical, Inc. · Cardiovascular

Dec 2022

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K221669 is an FDA 510(k) clearance for the IOB 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 December 27, 2022, 201 days after receiving the submission on June 9, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K221669 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2022
Decision Date	December 27, 2022
Days to Decision	201 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).