Cleared Traditional

K071918 - CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002

K071918 is an FDA 510(k) clearance for CHILLBUSTER PORTABLE ELECTRIC BLANKET, manufactured by Thermogear, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K071918 · Thermogear, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
120d
Days
Class 2
Risk

K071918 is an FDA 510(k) clearance for the CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Thermogear, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 120 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 Thermogear, Inc. devices

FDA 510(k) Submission Details - K071918

510(k) Number K071918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2007
Decision Date November 09, 2007
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 70
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K071918.
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · Covidien · Apr 2013
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
K100585 · Gaymar Industries, Inc. · Jan 2011
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
K083336 · Smiths Medical Asd, Inc. · Jun 2009
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · Smiths Medical Asd, Inc. · Aug 2006
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
K040632 · Smiths Medical Asd, Inc. · Apr 2004
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
K033021 · Kimberly-Clark Corp. · Nov 2003