510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043342Substantially Equivalent

Polyflux Family Hemodialyzer/filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6lr, 8Lr

Gambro Renal Products, Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043342 is the FDA 510(k) clearance record for POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR, a class II device, cleared for Gambro Renal Products on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 37 510(k) clearances for Gambro Renal Products, from to . As of , FDA records show no recalls naming K043342.

Clearance record

Decision date
Received
(172 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro Renal Products 10810 W Collins Ave., Lakewood CO
510(k) summary
Summary PDF
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