FDA product code LKM: Counter, Urine Particle
LKM is the FDA product code for counter, urine particle. It is a Class II device, regulated under 21 CFR 864.5200 and reviewed by the Hematology panel. FDA has cleared 15 510(k) submissions under LKM, 2 in the last five years, from 8 different applicants. The average 510(k) review took 116 days (median 64); 146 days on average over the last three years. FDA has posted 6 recalls for LKM devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Counter, Urine Particle |
| Device class | Class II |
| Regulation | 21 CFR 864.5200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LKM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 304 |
| 2020 | 1 | 224 |
| 2021 | 1 | 164 |
| 2024 | 1 | 266 |
| 2025 | 1 | 26 |
Compare with all 510(k) review times · Search every LKM clearance
Top LKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sysmex America, Inc. | 5 | 2018-04-23 |
| Beckman Coulter, Inc. | 2 | 2025-09-10 |
| Intl. Remote Imaging Systems | 2 | 2002-10-21 |
| Sysmex Corp. | 2 | 2001-09-28 |
| Arkray, Inc. | 1 | 2024-05-03 |
3 more applicants have LKM clearances. See the full list in Caduvo.
Most recent LKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252580 | Beckman Coulter, Inc. | iQ200 Series | 2025-09-10 | 26 |
| K232416 | Arkray, Inc. | AUTION EYE AI-4510 Urine Particle Analysis System | 2024-05-03 | 266 |
| K210127 | Beckman Coulter, Inc. | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | 2021-07-02 | 164 |
| K200811 | Roche Diagnostics | cobas u 701 microscopy analyzer | 2020-11-06 | 224 |
| K171883 | Sysmex America, Inc. | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | 2018-04-23 | 304 |
Recalls for LKM devices
6 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-12-19.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 4 |
Frequently asked questions
What is FDA product code LKM?
LKM is the FDA product code for counter, urine particle. It is a Class II device, regulated under 21 CFR 864.5200 and reviewed by the Hematology panel.
What device class is LKM?
Class II, regulation 21 CFR 864.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKM?
Across 15 cleared submissions the average was 116 days from receipt to decision (median 64).
Which companies have the most LKM clearances?
Sysmex America, Inc. (5); Beckman Coulter, Inc. (2); Intl. Remote Imaging Systems (2); Sysmex Corp. (2); Arkray, Inc. (1).
Have LKM devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2023-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LKM
- Run a recall and safety report across every LKM manufacturer
- Watch product code LKM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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