Cleared Traditional

K051278 - GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)

K051278 is an FDA 510(k) clearance for GERATHERM SOS-VACUTHERM (THERMAMED SMAR..., 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 408-day FDA review.

K051278 · Rg Ent., Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
408d
Days
Class 2
Risk

K051278 is an FDA 510(k) clearance for the GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE). 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 June 29, 2006 after a review of 408 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K051278

510(k) Number K051278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date June 29, 2006
Days to Decision 408 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
283d slower than avg
Panel avg: 125d · This submission: 408d
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 K051278.
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
GERATHERM SOS-RESCUE BAG
K051336 · R.G. Enterprises, Inc. · Jun 2006
HOT DOG PATIENT WARMING SYSTEM
K052392 · Augustine Biomedical & Design, LLC · May 2006
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1
K051419 · Inditherm Medical · Apr 2006
K051278 · GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
Download PDF FDA Summary Rg Ent., Inc.