510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933681Substantially Equivalent

Gambro Lundia Pro 100, 500, 600 Dialyzers

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

K933681 is the FDA 510(k) clearance record for GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS, a class II device, cleared for Cobe Renal Care, Inc. on under FDA product code FJG (Dialyzer, Parallel Flow). FDA records list 14 510(k) clearances for Cobe Renal Care, Inc., from to . As of , FDA records show no recalls naming K933681.

Clearance record

Decision date
Received
(405 days to decision)
Product code
FJG Dialyzer, Parallel Flow
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cobe Renal Care, Inc. 1185 Oak St., Lakewood CO
510(k) summary
Statement
Third party review
No

Clearances, product code FJG

Trailing 12 months

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

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