510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K060734Substantially Equivalent

Fresenius Com.tec Automated Cell Separator, Model 9008031; Fresenius C5l, S5l, C5l-T Platelet Sets (5-Day Storage)

Fresenius Medical Care Renal Therapies Group, LLC, Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060734 is the FDA 510(k) clearance record for FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE), cleared for Fresenius Medical Care North America on under FDA product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic). FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show no recalls naming K060734.

Clearance record

Decision date
Received
(169 days to decision)
Product code
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device class
Unclassified
Review panel
Unknown
Applicant
Fresenius Medical Care North America 95 Hayden Ave., Lexington MA
510(k) summary
Summary PDF
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260