Cleared Traditional

K930345 - TC2000 POWER UNIT AND ACCESSORIES

K930345 is an FDA 510(k) clearance for TC2000 POWER UNIT AND ACCESSORIES, 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 193-day FDA review.

K930345 · Gaymar Industries, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K930345

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.

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 K930345.
TC 3000
K942881 · Gaymar Industries, Inc. · May 1995
WARMTOUCH PLASTIC WARMING COVER
K943276 · Mallinckrodt Medical · Sep 1994
CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM
K940171 · Cabot Medical Corp. · Mar 1994
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540
K921165 · Augustine Medical, Inc. · Aug 1992
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
K920432 · Augustine Medical, Inc. · Jun 1992
BAIR HUGGER PATIENT WARMING SYSTEM
K920265 · Augustine Medical, Inc. · Mar 1992