510(k) · Cleared
ClearedChemstrip Super 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 Oct 14, 1993 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 14, 1993
- Review
- 56 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK934042 Chemstrip Super UA Urine AnalyzerBoehringer Mannheim Corp. · 1993
- Descendant · cites it directly · 1 of its ownK012397 Urisys 2400 Urine Test StripRoche Diagnostics Corp. · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK183432 cobas u 601 urinalysis test systemRoche Diagnostics · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK980047 Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp. · 1998
Most influential descendants
Showing 3 of 3 · See all- K012397Urisys 2400 Urine Test StripRoche Diagnostics Corp. · 2001 · cites it directly1descendant
- K183432cobas u 601 urinalysis test systemRoche Diagnostics · 2019 · 2 generations on0descendants
- K980047Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934042 | Chemstrip Super UA Urine Analyzer | Boehringer Mannheim Corp. | 1993 | — |
| +1 | K012397 | Urisys 2400 Urine Test Strip | Roche Diagnostics Corp. | 2001 | 1 |
| +2 | K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | 2019 | 1 |
| +1 | K980047 | Uriscan S-300 Semi-Automated Urine Chemistry Analyzer | Yeongdong Pharmaceutical Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2019 | 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? (3)
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?
- Of its descendants, K012397 (Roche Diagnostics Corp., 2001) has gone furthest, with 1 descendant 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/K934042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934042: Chemstrip Super UA 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/K934042
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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