510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970700Substantially Equivalent

Fresenius Polysulfone Hemodialyzers, Both Low and High Flux

Fresenius USA, Inc., Walnut Creek CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970700 is the FDA 510(k) clearance record for FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX, a class II device, cleared for Fresenius USA, Inc. on under FDA product code MSE (Hemodialyzer, Re-Use, Low Flux). FDA records list 38 510(k) clearances for Fresenius USA, Inc., from to . As of , FDA records show no recalls naming K970700.

Clearance record

Decision date
Received
(567 days to decision)
Product code
MSE Hemodialyzer, Re-Use, Low Flux
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius USA, Inc. 2637 Shadelands Dr., Walnut Creek CA
510(k) summary
Statement
Third party review
No

Clearances, product code MSE

Trailing 12 months

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

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