510(k) · Cleared
ClearedChemstrip Mini UA Urine Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · KQO Automated Urinalysis System
Cleared on Nov 8, 1994 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Nov 8, 1994
- Review
- 106 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- Descendant · cites it directly · 13 of its ownK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- Descendant · 2 generations on · 11 of its ownK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- Descendant · 3 generations on · 4 of its ownK093098 Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009
- Descendant · 3 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 · 4 generations on · 2 of its ownK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K983510Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998 · cites it directly13descendants
- K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002 · 2 generations on11descendants
- K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009 · 3 generations on4descendants
- K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · 3 generations on3descendants
- K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| +1 | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| +2 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| +3 | K093098 | Aution Max Model AX-4030 Urinalysis System | Arkray, Inc. | 2009 | — |
| +3 | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | 11 |
| +4 | K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983510 | Chemstrip 101 Urine Analyzer | 1998 | 13 |
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, K983510 (Boehringer Mannheim Corp., 1998) has gone furthest, with 13 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/K943592 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943592: Chemstrip Mini UA Urine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943592
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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