510(k) · Cleared
ClearedAUTION EYE AI-4510 Urine Particle Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · LKM Counter, Urine Particle
Cleared on May 3, 2024 as substantially equivalent to K093861 (Iris International, Inc., 2010) after a 266-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- May 3, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- LKM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093861 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK093861 IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina CradleIris International, Inc. · 2010 · Recalled
- This deviceK232416 AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093861 | IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina Cradle | Iris International, Inc. | 2010 | 4 |
| 0 (this device) | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKM device
- #1 K252580 iQ200 Seriesscore 9.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093861 | IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina CradleSummary page 6…alysis System Common Name: Automated cell counter (Urine particle counter) Predicate Device: Trade Name: iQ200 Urine Analyzer (K093861) Common Name: Automated Urinalysis System 5.1 Regulatory Information: Regulatory Classification for Automat… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K093861.
How does its category compare?
All LKM devicesLKM Counter, Urine Particle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LKM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKM
Too few LKM 510(k)s in any year since 2007 to give a median.
Recalls per year · LKM
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKM
1in 2021
MAUDE reports naming product code LKM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 4 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE)…
Read the full statement (128 words)
AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.
A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist.
The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232416: AUTION EYE AI-4510 Urine Particle Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232416
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026