Cleared Traditional

BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS

K101589 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular

Sep 2010

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K101589 is an FDA 510(k) clearance for the BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Cincinnati Sub-Zero Products, Inc. (Sharonville, US). The FDA issued a Cleared decision on September 20, 2010, 105 days after receiving the submission on June 7, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K101589 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2010
Decision Date	September 20, 2010
Days to Decision	105 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).