FDA Product Code LKM: Counter, Urine Particle
FDA product code LKM covers urine particle counters used in clinical urinalysis.
These automated analyzers use flow cytometry or digital imaging to identify and count formed elements in urine — including red blood cells, white blood cells, casts, bacteria, and epithelial cells — replacing manual microscopy in high-volume laboratories with faster, more reproducible results.
LKM devices are Class II medical devices, regulated under 21 CFR 864.5200 and reviewed by the FDA Hematology panel.
Leading manufacturers include Sysmex America, Inc., Intl. Remote Imaging Systems and Sysmex Corp..
15
Total
15
Cleared
116d
Avg days
1982
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
26d
recently vs 123d historically
FDA 510(k) Cleared Counter, Urine Particle Devices (Product Code LKM)
15 devices
Cleared
Sep 10, 2025
iQ200 Series
Beckman Coulter, Inc.
Hematology
26d
Cleared
May 03, 2024
AUTION EYE AI-4510 Urine Particle Analysis System
Arkray, Inc.
Immunology
266d
Cleared
Jul 02, 2021
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
Beckman Coulter, Inc.
Hematology
164d
Cleared
Nov 06, 2020
cobas u 701 microscopy analyzer
Roche Diagnostics
Hematology
224d
Cleared
Apr 23, 2018
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
Sysmex America, Inc.
Hematology
304d
Cleared
Feb 05, 2010
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
Iris International, Inc.
Pathology
51d
Cleared
Feb 03, 2009
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
Sysmex America, Inc.
Pathology
118d
Cleared
May 02, 2008
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
Sysmex America, Inc.
Pathology
32d
Cleared
May 25, 2007
SYSMEX MODEL UF1000I
Sysmex America, Inc.
Pathology
53d
Cleared
Jan 04, 2006
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
Sysmex America, Inc.
Pathology
57d
Cleared
Oct 21, 2002
IQ 200 SYSTEM
Intl. Remote Imaging Systems
Pathology
61d
Cleared
Sep 28, 2001
SYSMEX UF-50
Sysmex Corp.
Pathology
64d
Cleared
Apr 14, 2000
939UDX URINE PATHOLOGY SYSTEM
Intl. Remote Imaging Systems
Pathology
70d
Cleared
Oct 28, 1996
SYSMEX UF-100
Sysmex Corp.
Pathology
224d
Cleared
Oct 18, 1982
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
Eko Scann AB
Hematology
27d
About Product Code LKM - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code LKM since 1982, with 15 receiving FDA clearance (average review time: 116 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - LKM Product Code
Recent submissions under LKM have taken an average of 26 days to reach a decision - down from 123 days historically, suggesting improved FDA processing for this classification.
LKM devices are reviewed by the Pathology panel. Browse all Pathology devices →