510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904566Substantially Equivalent

New Cobe Centrysystem(tm) 100 Hg Dialyzer

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

K904566 is the FDA 510(k) clearance record for NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER, a class II device, cleared for Cobe Laboratories, Inc. on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 77 510(k) clearances for Cobe Laboratories, Inc., from to . As of , FDA records show no recalls naming K904566.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cobe Laboratories, Inc. 1185 Oak St., Lakewood CO
Third party review
No

Clearances, product code FJI

Trailing 12 months

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

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