Cleared Traditional

K930345 - TC2000 POWER UNIT AND ACCESSORIES

K930345 is the FDA 510(k) clearance for TC2000 POWER UNIT AND ACCESSORIES by Gaymar Industries, Inc.. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K930345 · Gaymar Industries, Inc. · Cardiovascular device
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Aug 1993
Decision
193d
Days
Class 2
Risk

K930345 is an FDA 510(k) clearance for the TC2000 POWER UNIT AND ACCESSORIES. 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 August 6, 1993 after a review of 193 days - an extended review cycle.

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 Gaymar Industries, Inc. devices

Submission Details

510(k) Number K930345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1993
Decision Date August 06, 1993
Days to Decision 193 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 125d · This submission: 193d
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 K930345.
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K900186 · Shiley, Inc. · Apr 1990
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K882442 · Baxter Healthcare Corp · Sep 1988
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K882035 · Buckman Co., Inc. · Jul 1988