510(k) · Cleared
ClearedAution Max Model AX-4030 Urinalysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · KQO Automated Urinalysis System
Cleared on Dec 23, 2009 as substantially equivalent to K013783 (International Remote Imaging Systems, 2002) after an 83-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 83 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943592 (1994). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- 2 generations backK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- 1 generation backK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- This deviceK093098 Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK193514 AUTION MAX AX-4060 Urinalysis SystemArkray, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK160062 AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK121456 Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer…Arkray, Inc. · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · cites it directly0descendants
- K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc. · 2023 · cites it directly0descendants
- K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. · 2016 · cites it directly0descendants
- K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…Arkray, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| −2 | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| 0 (this device) | K093098 | Aution Max Model AX-4030 Urinalysis System | Arkray, Inc. | 2009 | — |
| +1 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
| +1 | K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | 2023 | — |
| +1 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016 | — |
| +1 | K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System… | Arkray, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
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 KQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K013783 | Aution Max AX-4280 Urinalysis SystemSummary page 1…Urinalysis System Class: I'lIl CFR Section: 21 CFR 862.2900, 21 CFR 862.1340, 21 CFR 864-6650 Predicate Devices: K0 13 783 AUTION MAX AX-4280 Urinalysis System (AiRKRAY, Inc.) Device Description: The AX-4030 device is com… | 2002 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine… | 2024 | 0 |
| K193514 | AUTION MAX AX-4060 Urinalysis System | 2023 | 0 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | 2016 | 0 |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA… | 2013 | 0 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K232317 (Urit Medical Electronic Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K013783.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, 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 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTLON MAX is intended for use only with AUTLON Sticks 9EB multi-parameter test strips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093098: Aution Max Model AX-4030 Urinalysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093098
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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