510(k) · Cleared
ClearedClinitek Atlas Automated Urine Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · KQO Automated Urinalysis System
Cleared on Feb 22, 1995 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 22, 1995
- Review
- 64 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK946183 Clinitek Atlas Automated Urine Chemistry AnalyzerHeraeus Kulzer, Inc. · 1995
- Descendant · cites it directly · 11 of its ownK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- Descendant · 2 generations on · 4 of its ownK093098 Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK030600 Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002 · cites it directly11descendants
- K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009 · 2 generations on4descendants
- K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · 2 generations on3descendants
- K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017 · 3 generations on2descendants
- K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946183 | Clinitek Atlas Automated Urine Chemistry Analyzer | Heraeus Kulzer, Inc. | 1995 | — |
| +1 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| +2 | K093098 | Aution Max Model AX-4030 Urinalysis System | Arkray, Inc. | 2009 | — |
| +2 | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | 11 |
| +3 | K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017 | — |
| +1 | K030600 | Aution Jet AJ-4270 Urine Analyzer | International Remote Imaging Systems | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 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?
- Of its descendants, K013783 (International Remote Imaging Systems, 2002) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K946183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946183: Clinitek Atlas Automated Urine Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946183
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026