510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012372Substantially Equivalent

Sysmex Uf-50

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

K012372 is the FDA 510(k) clearance record for SYSMEX UF-50, a class II device, cleared for Sysmex Corp. on under FDA product code LKM (Counter, Urine Particle). FDA records list 18 510(k) clearances for Sysmex Corp., from to . As of , FDA records show no recalls naming K012372.

Clearance record

Decision date
Received
(64 days to decision)
Product code
LKM Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Sysmex Corp. Gilmer Rd., Long Grove IL
510(k) summary
Summary
Third party review
No

Clearances, product code LKM

Trailing 12 months

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

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