510(k) · Cleared
ClearedCobas U411 Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · KQO Automated Urinalysis System
Cleared on Apr 2, 2010 as substantially equivalent to K921087 (Boehringer Mannheim Corp., 1992) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Apr 2, 2010
- Review
- 136 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921087 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K183432cobas u 601 urinalysis test systemRoche Diagnostics · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921087 | Chemstrip Urine Analyzer | Boehringer Mannheim Corp. | 1992 | — |
| 0 (this device) | K093555 | Cobas U411 Test System | Roche Diagnostics | 2010 | — |
| +1 | K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K921087 | Chemstrip Urine AnalyzerSummary page 2…ubstantially equivalent to equivalence other devices legally marketed in the United States. We claim equivalence to the Chemstrip Urine Analyzer (K921087 and K(93 1602). Both instruments are designed to provide semi-quantitative results using a re… | 1992 |
| * | K931602 | Chemstrip Urine Analyzer | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183432 | cobas u 601 urinalysis test system | 2019 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K183432 (Roche Diagnostics, 2019) has gone furthest, with 0 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. 2010, 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?
The cobas 1141 1 urine analyzer is a semi-automated, benchtop analyzer which is designed
to read the Chemstrip 10 UA (Combur' 0 Test M) test strips for urinalysis for the
measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific
gravity, urobilinogen and color (if selected). These measurements are useful in the
evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas
u41 I are intended for prescription, in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093555: Cobas U411 Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093555
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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