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 Beckman Coulter, Inc., Sysmex America, Inc. and Roche Diagnostics.
FDA 510(k) Cleared Counter, Urine Particle Devices (Product Code LKM)
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 Review Time
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 Hematology panel. Browse all Hematology devices →