Data / Medical devices / Counter, Urine Particle
Counter, Urine Particle (LKM): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Counter, Urine Particle (product code LKM, Class 2, 21 CFR 864.5200). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on September 10, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LKM
- Device class
- 2
- Regulation
- 864.5200
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| Japan | 4 |
| United States | 4 |
Makers of Counter, Urine Particle
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ARKRAY Factory, Inc. | Koka-shi Shiga, Japan | Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 1 | October 21, 2002 | 0 | 1 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 1 | April 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| SYSMEX CORPORATION i-SQUARE | Kakogawa Hyogo, Japan | Manufacturer | 1 | April 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Manufacturer | 1 | April 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Manufacturer | 1 | April 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.