510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K942303Substantially Equivalent

Tecnadyne T-Cuff

Technadyne Scientific, Inc., Vero Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942303 is the FDA 510(k) clearance record for TECNADYNE T-CUFF, a class I device, cleared for Technadyne Scientific, Inc. on under FDA product code KCY (Tourniquet, Pneumatic). FDA records list one 510(k) clearance for Technadyne Scientific, Inc. As of , FDA records show no recalls naming K942303.

Clearance record

Decision date
Received
(68 days to decision)
Product code
KCY Tourniquet, Pneumatic
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Technadyne Scientific, Inc. 546 1st St., Vero Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code KCY

Trailing 12 months

FDA records hold no clearances under product code KCY in the trailing twelve months.

FDA records show no clearances under product code KCY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KCY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260