Cleared Traditional

GERATHERM SOS-RESCUE BAG (K051336) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051336 · R.G. Enterprises, Inc. · Cardiovascular device
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Jun 2006
Decision
402d
Days
Class 2
Risk

K051336 is an FDA 510(k) clearance for the GERATHERM SOS-RESCUE BAG. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by R.G. Enterprises, Inc. (Southfield, US). The FDA issued a Cleared decision on June 29, 2006 after a review of 402 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.

View all R.G. Enterprises, Inc. devices

Submission Details

510(k) Number K051336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2005
Decision Date June 29, 2006
Days to Decision 402 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 125d · This submission: 402d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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