510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915504Substantially Equivalent

Gambro Lundia Alpha Hemodialyzers

C.G.H. Medical, Inc., Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915504 is the FDA 510(k) clearance record for GAMBRO LUNDIA ALPHA HEMODIALYZERS, a class II device, cleared for C.G.H. Medical, Inc. on under FDA product code FJG (Dialyzer, Parallel Flow). FDA records list 11 510(k) clearances for C.G.H. Medical, Inc., from to . As of , FDA records show no recalls naming K915504.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FJG Dialyzer, Parallel Flow
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.G.H. Medical, Inc. 1185 Oak St., Lakewood CO
510(k) summary
Summary
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