510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954201Substantially Equivalent

Buonafede Pneumatic Sleeve

Promedic, Inc., Sturgis MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954201 is the FDA 510(k) clearance record for BUONAFEDE PNEUMATIC SLEEVE, a class I device, cleared for Promedic, Inc. on under FDA product code KCY (Tourniquet, Pneumatic). FDA records list 16 510(k) clearances for Promedic, Inc., from to . As of , FDA records show no recalls naming K954201.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KCY Tourniquet, Pneumatic
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Promedic, Inc. 67920 Klinger Lake Rd., Sturgis MI
510(k) summary
Summary
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