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
K053135Substantially Equivalent

Sysmex Uf-100I Automated Urine Cell Analyzer

Sysmex America, Inc., Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053135 is the FDA 510(k) clearance record for SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER, a class II device, cleared for Sysmex America, Inc. on under FDA product code LKM (Counter, Urine Particle). FDA records list 31 510(k) clearances for Sysmex America, Inc., from to . As of , FDA records show no recalls naming K053135.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LKM Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Sysmex America, Inc. One Nelson C. White Pkwy., Mundelein IL
510(k) summary
Summary PDF
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