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
K063114Substantially Equivalent

Disposable Transfer Sets with and without Swabbable Valves And/or Check Valves

Coeur, Inc., Lebanon TN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063114 is the FDA 510(k) clearance record for DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES, a class II device, cleared for Coeur, Inc. on under FDA product code FPK (Tubing, Fluid Delivery). FDA records list 14 510(k) clearances for Coeur, Inc., from to . As of , FDA records show no recalls naming K063114.

Clearance record

Decision date
Received
(121 days to decision)
Product code
FPK Tubing, Fluid Delivery
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Coeur, Inc. 704 Cadet Ct., Lebanon TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPK

Trailing 12 months

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

FDA records show no clearances under product code FPK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPK, 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