510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K802250Substantially Equivalent

Dialysis Control Unit-Centry 2000

Cobe Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802250 is the FDA 510(k) clearance record for DIALYSIS CONTROL UNIT-CENTRY 2000, a class II device, cleared for Cobe Laboratories, Inc. on under FDA product code FKP (System, Dialysate Delivery, Single Patient). FDA records list 77 510(k) clearances for Cobe Laboratories, Inc., from to . As of , FDA records show no recalls naming K802250.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FKP System, Dialysate Delivery, Single Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cobe Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKP

Trailing 12 months

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

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