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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWJ System, Thermal Regulating

All 156
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K071918.
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
K073712 · Adroit Medical Systems, Inc. · Jun 2008
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
K080763 · Talley Medical · May 2008
DM-EMG
K072513 · Gvp Elettronica Srl · Dec 2007
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K071341 · Medivance, Inc. · Aug 2007
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
K070112 · Medcool, Inc. · Jul 2007
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
K061902 · Inditherm Medical · Dec 2006
K071918 · CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
Download PDF FDA Summary Thermogear, Inc.