510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950508Substantially Equivalent

Sysmex Sf-3000

Sysmex Corporation, Long Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950508 is the FDA 510(k) clearance record for SYSMEX SF-3000, a class II device, cleared for Sysmex Corp. on under FDA product code FPK (Tubing, Fluid Delivery). FDA records list 18 510(k) clearances for Sysmex Corp., from to . As of , FDA records show no recalls naming K950508.

Clearance record

Decision date
Received
(270 days to decision)
Product code
FPK Tubing, Fluid Delivery
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Sysmex Corp. 6699 Rfd, Long Grove IL
510(k) summary
Summary
Third party review
No

Clearances, product code FPK

Trailing 12 months

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

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