Cleared Traditional

K070112 - RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM

K070112 is an FDA 510(k) clearance for RAPIDCOOL PATIENT TEMPERATURE MANAGEMEN..., manufactured by Medcool, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K070112 · Medcool, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
183d
Days
Class 2
Risk

K070112 is an FDA 510(k) clearance for the RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Medcool, Inc. (North Reading, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 183 days - an extended review cycle.

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 - K070112

510(k) Number K070112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2007
Decision Date July 13, 2007
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
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 156
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K070112.
DM-EMG
K072513 · Gvp Elettronica Srl · Dec 2007
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
K071918 · Thermogear, Inc. · Nov 2007
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K071341 · Medivance, Inc. · Aug 2007
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
K061902 · Inditherm Medical · Dec 2006
PRN THERMALCARE, MODEL 3000
K062794 · American Healthcare Products, Inc. · Dec 2006
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · Smiths Medical Asd, Inc. · Aug 2006
K070112 · RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
Download PDF FDA Summary Medcool, Inc.