Cleared Traditional

K140635 - COCOON CONVECTIVE WARMING SYSTEM

K140635 is an FDA 510(k) clearance for COCOON CONVECTIVE WARMING SYSTEM, manufactured by Care Essentials Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K140635 · Care Essentials Pty, Ltd. · Cardiovascular device
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Jul 2014
Decision
135d
Days
Class 2
Risk

K140635 is an FDA 510(k) clearance for the COCOON CONVECTIVE WARMING SYSTEM. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Care Essentials Pty, Ltd. (Parkside, South Australia, AU). The FDA issued a Cleared decision on July 25, 2014 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Care Essentials Pty, Ltd. devices

FDA 510(k) Submission Details - K140635

510(k) Number K140635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2014
Decision Date July 25, 2014
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 135
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K140635.
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
K142702 · Medivance, Inc. · Dec 2014
TECOTHERM NEO (T NEO)
K140078 · Inspiration Healthcare, Ltd. · Nov 2014
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
K141686 · Smith Medical Asd, Inc. · Oct 2014
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · Molnlycke Health Care Us, LLC · Nov 2013
VITAHEAT PATIENT WARMING SYSTEM
K132454 · Vitaheat Medical, LLC · Oct 2013
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
K131361 · Covidien · Jul 2013