510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914805Substantially Equivalent

Tc-1000, Tc-1050 System

Gaymar Industries, Inc., Orchard Park NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914805 is the FDA 510(k) clearance record for TC-1000, TC-1050 SYSTEM, a class II device, cleared for Gaymar Industries, Inc. on under FDA product code DWJ (System, Thermal Regulating). FDA's definition for product code DWJ reads: "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...". FDA records list 27 510(k) clearances for Gaymar Industries, Inc., from to . As of , FDA records show no recalls naming K914805.

Clearance record

Decision date
Received
(75 days to decision)
Product code
DWJ System, Thermal Regulating
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Gaymar Industries, Inc. 10 Centre Dr., Orchard Park NY
510(k) summary
Statement
Third party review
No

Clearances, product code DWJ

Trailing 12 months
5 clearances under product code DWJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20262
September 20260
October 20260