AUTION EYE AI-4510 Urine Particle Analysis System
FDA 510(k) K232416 · Arkray, Inc.
510(k) numberK232416
Submission
- Device name
- AUTION EYE AI-4510 Urine Particle Analysis System
- Applicant
- Arkray, Inc.
Kyoto, JP - Received
- August 11, 2023
- Decision date
- May 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKM – Counter, Urine Particle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code LKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252580 | iQ200 SeriesLKM · Special | Beckman Coulter, Inc. | 09/10/2025SE |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemLKM · Traditional | Beckman Coulter, Inc. | 07/02/2021SE |
| K200811 | cobas u 701 microscopy analyzerLKM · Traditional | Roche Diagnostics | 11/06/2020SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | Sysmex America, Inc. | 04/23/2018SE |
| K093861 | Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina CradleLKM · Special | Iris International, Inc. | 02/05/2010SE |
| K083002 | Sysmex UF-500I Automated Urine Particle AnalyzerLKM · Special | Sysmex America, Inc. | 02/03/2009SE |
| K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareLKM · Special | Sysmex America, Inc. | 05/02/2008SE |
| K070910 | Sysmex Model UF1000ILKM · Traditional | Sysmex America, Inc. | 05/25/2007SE |
| K053135 | Sysmex UF-100I Automated Urine Cell AnalyzerLKM · Traditional | Sysmex America, Inc. | 01/04/2006SE |
| K022774 | Iq 200 SystemLKM · Traditional | Intl. Remote Imaging Systems | 10/21/2002SE |
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| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | 04/13/2023SE |
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| K200788 | Assure Titanium Blood Glucose Monitoring SystemPZI · Dual Track | 05/23/2022SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | 10/07/2016SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | 02/01/2013SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | 12/23/2009SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | 03/24/2006SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | 01/31/2006SE |
| K051432 | Spotchem II Total Bilirubin, Total Protein and Albumin TestsCIG · Traditional | 06/17/2005SE |
| K050790 | Spotchem II LDH TestCFH · Traditional | 06/06/2005SE |
Questions and answers
When was AUTION EYE AI-4510 Urine Particle Analysis System cleared by the FDA?
AUTION EYE AI-4510 Urine Particle Analysis System (K232416) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 266 days after the submission was received.
What is the product code of K232416?
The FDA product code is LKM – Counter, Urine Particle, a Class II (moderate risk) device regulated under 21 CFR 864.5200.