510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895435Substantially Equivalent

Fresenius as 104 Cell Separator

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

K895435 is the FDA 510(k) clearance record for FRESENIUS AS 104 CELL SEPARATOR, cleared for Fresenius USA, Inc. on under FDA product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic). FDA records list 38 510(k) clearances for Fresenius USA, Inc., from to . As of , FDA records show no recalls naming K895435.

Clearance record

Decision date
Received
(421 days to decision)
Product code
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device class
Unclassified
Review panel
Unknown
Applicant
Fresenius USA, Inc. 4090 Pike Ln., Concord CA
Third party review
No

Clearances, product code LKN

Trailing 12 months

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

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