Cleared Traditional

K093244 - UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX

K093244 is an FDA 510(k) clearance for UNIQUE TEMP WARMING BLANKETS, manufactured by Geratherm Medical AG. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 369-day FDA review.

K093244 · Geratherm Medical AG · Cardiovascular device
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Oct 2010
Decision
369d
Days
Class 2
Risk

K093244 is an FDA 510(k) clearance for the UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Geratherm Medical AG (Tuttlingen, Baden Wurttemberg, DE). The FDA issued a Cleared decision on October 19, 2010 after a review of 369 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.

View all Geratherm Medical AG devices

FDA 510(k) Submission Details - K093244

510(k) Number K093244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2009
Decision Date October 19, 2010
Days to Decision 369 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
244d slower than avg
Panel avg: 125d · This submission: 369d
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 69
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K093244.
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
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K100585 · Gaymar Industries, Inc. · Jan 2011
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
K083336 · Smiths Medical Asd, Inc. · Jun 2009
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · Smiths Medical Asd, Inc. · Aug 2006
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
K040632 · Smiths Medical Asd, Inc. · Apr 2004