510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023615Substantially Equivalent

Gambro Polyflux 6 Lr, 8 Lr and 10 Lr

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

K023615 is the FDA 510(k) clearance record for GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR, a class II device, cleared for Gambro Renal Products on under FDA product code MSF (Hemodialyzer, Re-Use, High Flux). FDA records list 37 510(k) clearances for Gambro Renal Products, from to . As of , FDA records show no recalls naming K023615.

Clearance record

Decision date
Received
(190 days to decision)
Product code
MSF Hemodialyzer, Re-Use, High Flux
Regulation
21 CFR 876.5860
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 MSF

Trailing 12 months

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

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