510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862716Substantially Equivalent

Hemofiltration System 10

Gambro, Inc., Lincolnshire IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862716 is the FDA 510(k) clearance record for HEMOFILTRATION SYSTEM 10, a class II device, cleared for Gambro, Inc. on under FDA product code FII (System, Dialysate Delivery, Sealed). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K862716.

Clearance record

Decision date
Received
(54 days to decision)
Product code
FII System, Dialysate Delivery, Sealed
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro, Inc. 600 Knightsbridge Pkwy., Lincolnshire IL
Third party review
No

Clearances, product code FII

Trailing 12 months

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

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