Cleared Traditional

K942881 - TC 3000

K942881 is the FDA 510(k) clearance for TC 3000 by Gaymar Industries, Inc.. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K942881 · Gaymar Industries, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
340d
Days
Class 2
Risk

K942881 is an FDA 510(k) clearance for the TC 3000. 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 May 23, 1995 after a review of 340 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

Submission Details

510(k) Number K942881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1994
Decision Date May 23, 1995
Days to Decision 340 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
215d slower than avg
Panel avg: 125d · This submission: 340d
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.

Regulatory Peers - DWJ System, Thermal Regulating

All 38
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K942881.
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · Smiths Medical Asd, Inc. · Aug 2006
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K040632 · Smiths Medical Asd, Inc. · Apr 2004
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K033021 · Kimberly-Clark Corp. · Nov 2003
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · Shiley, Inc. · Apr 1990
RK2000 K-THERMIA SYSTEM
K882442 · Baxter Healthcare Corp · Sep 1988
HEART-CHILL SALINE SLUSH PAD
K882035 · Buckman Co., Inc. · Jul 1988