Cleared Traditional

K051097 - GERATHERM SOS-RESCUE BLANKET

K051097 is an FDA 510(k) clearance for GERATHERM SOS-RESCUE BLANKET, manufactured by Rg Ent., Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K051097 · Rg Ent., Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
301d
Days
Class 2
Risk

K051097 is an FDA 510(k) clearance for the GERATHERM SOS-RESCUE BLANKET. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Rg Ent., Inc. (Southfield, US). The FDA issued a Cleared decision on February 24, 2006 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K051097

510(k) Number K051097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date February 24, 2006
Days to Decision 301 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
176d slower than avg
Panel avg: 125d · This submission: 301d
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 K051097.
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1
K051419 · Inditherm Medical · Apr 2006
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
K060865 · Arizant Healthcare, Inc. · Apr 2006
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K053645 · Arizant Healthcare, Inc. · Mar 2006
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
K031728 · Klimamed Technologie Medizingerate GmbH · Oct 2004
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K041686 · Arizant Healthcare, Inc. · Jun 2004
VITALHEAT
K040911 · Dynatherm Medical, Inc. · Jun 2004
K051097 · GERATHERM SOS-RESCUE BLANKET
Download PDF FDA Summary Rg Ent., Inc.