Cleared Traditional

K092807 - HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103

K092807 is an FDA 510(k) clearance for HOT DOG PATIENT WARMING MATTRESS SYSTEM, manufactured by Augustine Biomedical & Design, LLC. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K092807 · Augustine Biomedical & Design, LLC · Cardiovascular device
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Dec 2009
Decision
90d
Days
Class 2
Risk

K092807 is an FDA 510(k) clearance for the HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Augustine Biomedical & Design, LLC (Eden Prairie, US). The FDA issued a Cleared decision on December 10, 2009 after a review of 90 days - within the typical 510(k) review window.

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.

View all Augustine Biomedical & Design, LLC devices

FDA 510(k) Submission Details - K092807

510(k) Number K092807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date December 10, 2009
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 67
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K092807.
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