Cleared Traditional

K100585 - MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900

K100585 is an FDA 510(k) clearance for MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, manufactured by Gaymar Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K100585 · Gaymar Industries, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2011
Decision
324d
Days
Class 2
Risk

K100585 is an FDA 510(k) clearance for the MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 324 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 Gaymar Industries, Inc. devices

FDA 510(k) Submission Details - K100585

510(k) Number K100585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date January 20, 2011
Days to Decision 324 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
199d slower than avg
Panel avg: 125d · This submission: 324d
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 89
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K100585.
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
K120081 · Cincinnati Sub-Zero Products, Inc. · Feb 2012
HOTDOG PATIENT WARMING SYSTEM
K112488 · Augustine Biomedical & Design, LLC · Nov 2011
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
K110104 · Cincinnati Sub-Zero Products, Inc. · Feb 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