510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K123553Substantially Equivalent

Zimmer A.t.s. 4000Ts Automatic Tourniquet System

Zimmer GmbH, Indianpolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123553 is the FDA 510(k) clearance record for ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM, a class I device, cleared for Zimmer, Inc. on under FDA product code KCY (Tourniquet, Pneumatic). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show one recall naming K123553.

Clearance record

Decision date
Received
(263 days to decision)
Product code
KCY Tourniquet, Pneumatic
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Zimmer, Inc. 9001 Wesleyan Rd., Indianpolis IN
510(k) summary
Summary PDF
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