510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K880020Substantially Equivalent

3 in 1 Automatic Tourniquet

Systematics Mfg. & Tool Co., Inc., Bohemia NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880020 is the FDA 510(k) clearance record for 3 IN 1 AUTOMATIC TOURNIQUET, a class I device, cleared for Systematics Mfg. & Tool Co., Inc. on under FDA product code KCY (Tourniquet, Pneumatic). FDA records list one 510(k) clearance for Systematics Mfg. & Tool Co., Inc. As of , FDA records show no recalls naming K880020.

Clearance record

Decision date
Received
(72 days to decision)
Product code
KCY Tourniquet, Pneumatic
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Systematics Mfg. & Tool Co., Inc. 1555-F Ocean Ave., Bohemia NY
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