510(k) · Cleared
ClearedAution Jet AJ-4270 Urine Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Remote Imaging Systems · KQO Automated Urinalysis System
Cleared on Jul 11, 2003 as substantially equivalent to K983510 (Boehringer Mannheim Corp., 1998) and 2 other predicates after a 136-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 11, 2003
- Review
- 136 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943592 (1994). 4 ancestors in all. 2 later devices descend from it, 2 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 deviceK030600 Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
- Descendant · cites it directly · 0 of its ownK160062 AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK060280 Ichem 100 Urine Chemistry AnalyzerIris International, Inc. · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K030600 | Aution Jet AJ-4270 Urine Analyzer | International Remote Imaging Systems | 2003 | — |
| +1 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016 | — |
| +1 | K060280 | Ichem 100 Urine Chemistry Analyzer | Iris International, Inc. | 2006 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K983510 | Chemstrip 101 Urine AnalyzerSummary page 1…r Classification Name: Automated Urinalysis System 3. PREDICATE DEVICES 0 Chemstrip 101 Urine Analyzer (K9835 10) 0 AUTION MAXTMAX-4280 Urine Analyzer (KO13783) e Clinitek Atlas Automated Urine Chemistry A… | 1998 |
| * | K013783 | Aution Max AX-4280 Urinalysis System | 2002 |
| * | K946183 | Clinitek Atlas Automated Urine Chemistry AnalyzerSummary page 1…(K9835 10) 0 AUTION MAXTMAX-4280 Urine Analyzer (KO13783) e Clinitek Atlas Automated Urine Chemistry Analyzer (K946 183) 4. DEVICEDESCRIPTION The AUTIONTMJET AJ-4270 Urine Analyzer (AUTIONTMJET) consists of an analyzer and access… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K160062 (Arkray, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K983510.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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™JET AJ-4270 Urine Analyzer (AUTION™JET) is a semi-automated urine analyzer and is intended for use with the AUTION™ Sticks 10EA multi-parameter test strips for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocytes, and color. The AUTION™JET Analyzer and AUTION™Sticks 10EA test strips are intended for mutually exclusive use as a system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030600: Aution Jet AJ-4270 Urine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030600
Report an extraction error
Are you the manufacturer?
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