Cleared Special

Cocoon Convective Warming System

K181671 · Care Essentials Pty, Ltd. · Cardiovascular

May 2019

Decision

311d

Days

Class 2

Risk

About This 510(k) Submission

K181671 is an FDA 510(k) clearance for the Cocoon Convective Warming System, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Care Essentials Pty, Ltd. (North Geelong, AU). The FDA issued a Cleared decision on May 2, 2019, 311 days after receiving the submission on June 25, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K181671 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2018
Decision Date	May 02, 2019
Days to Decision	311 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Statement

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).