510(k) · Cleared
Recalled · Class II · 2019Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control
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 Feb 1, 2013 as substantially equivalent to K093098 (Arkray, Inc., 2009) and 2 other predicates after a 261-day review. Its family tree reaches back 4 generations to 1990. It has been recalled once.
- Decided
- Feb 1, 2013
- Review
- 261 days
- Class
- Class I
- Product code
- KQO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K900484 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK900484 Ret-CheckStreck Laboratories, Inc. · 1990
- 3 generations backK961054 Sysmex UF-100Sysmex Corp. · 1996
- 2 generations backK070910 Sysmex Model UF1000ISysmex America, Inc. · 2007
- 1 generation backK080887 Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis…Sysmex America, Inc. · 2008 · Recalled
- This deviceK121456 Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer…Arkray, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900484 | Ret-Check | Streck Laboratories, Inc. | 1990 | — |
| −3 | K961054 | Sysmex UF-100 | Sysmex Corp. | 1996 | — |
| −2 | K070910 | Sysmex Model UF1000I | Sysmex America, Inc. | 2007 | — |
| −1 | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software | Sysmex America, Inc. | 2008 | 1 |
| 0 (this device) | K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System… | Arkray, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K093098 | Aution Max Model AX-4030 Urinalysis SystemSummary page 2…ne Leukocyte 862.2900 JRE Class I Refractometer for Clinical Use Predicate Devices AUTION MAX AX-4030 Urinalysis System (k093098) SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (k080887) Sysmex UF-11 Control (k0709 10) Device… | 2009 |
| * | K080887 | Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareSummary page 2…ometer for Clinical Use Predicate Devices AUTION MAX AX-4030 Urinalysis System (k093098) SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (k080887) Sysmex UF-11 Control (k0709 10) Device Description The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The A… | 2008 |
| * | K070910 | Sysmex Model UF1000ISummary page 2…cate Devices AUTION MAX AX-4030 Urinalysis System (k093098) SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (k080887) Sysmex UF-11 Control (k0709 10) Device Description The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU- 4050 contains a test strip ch… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2019 | Class II | Z-1850-2019 | Software design | This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 3 other devices also cite its predicate K093098.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
AUTION HYBRID T M AU-4050 Fully Automated Integrated Urine Analyzer System The AUTION HYBRID T M AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (OHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin…
Read the full statement (239 words)
AUTION HYBRID T M AU-4050 Fully Automated Integrated Urine Analyzer System
The AUTION HYBRID T M AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (OHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet TM S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Uriflet TM S 9HA Urine Test Strips
Uriflet TM S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.
AUTION TM Control Solution
The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AUA4050 flow cytometry module.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121456: Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121456
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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