Cleared Traditional

IOB Warming Blankets

K190221 · Iob Medical, Inc. · Cardiovascular

Oct 2019

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K190221 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 October 25, 2019, 262 days after receiving the submission on February 5, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K190221 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2019
Decision Date	October 25, 2019
Days to Decision	262 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).