510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850435Substantially Equivalent

Sartorius Aquasart Sm 40035 - Dialysate Sys

Sartorius Filters, Inc., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850435 is the FDA 510(k) clearance record for SARTORIUS AQUASART SM 40035 - DIALYSATE SYS, a class II device, cleared for Sartorius Filters, Inc. on under FDA product code FKR (Subsystem, Proportioning). FDA records list 8 510(k) clearances for Sartorius Filters, Inc., from to . As of , FDA records show no recalls naming K850435.

Clearance record

Decision date
Received
(120 days to decision)
Product code
FKR Subsystem, Proportioning
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sartorius Filters, Inc. 26575 Corporate Ave., Hayward CA
Third party review
No

Clearances, product code FKR

Trailing 12 months

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

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