510(k) · Cleared
Recalled · 2004Clinitek 50 Urine Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · KQO Automated Urinalysis System
Cleared on Jun 12, 1996 after a 125-day review. The FDA summary names its predicate without a number. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 12, 1996
- Review
- 125 days
- Class
- Class I
- Product code
- KQO
- Recalls
- 2
- Predicates
- 0
22 later devices descend from it, 6 citing it directly.
- This deviceK960546 Clinitek 50 Urine Chemistry AnalyzerBayer Corp. · 1996
- Descendant · cites it directly · 16 of its ownK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- Descendant · 2 generations on · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK070929 Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003 · cites it directly16descendants
- K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · 2 generations on6descendants
- K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · 2 generations on3descendants
- K070929Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007 · 2 generations on3descendants
- K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960546 | Clinitek 50 Urine Chemistry Analyzer | Bayer Corp. | 1996 | — |
| +1 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| +2 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| +2 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (… | ACON Laboratories, Inc. | 2014 | — |
| +2 | K070929 | Acon U120 Urine Analyzer, Model U111-101 | ACON Laboratories, Inc. | 2007 | — |
| +3 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | MULTISTIX 10-SG Reagent Strips for Urinalysis (visual readout) Named without a submission number | |
| * | — | CLINITEK 200+ Urine Chemistry Analyzer Named without a submission number | |
| * | — | CLINITEK ATLAS Urine Chemistry Analyzer Named without a submission number |
What descends from it? (22)
See all 226 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031947 | Bayer Clinitek Status Analyzer | 2003 | 16 |
| K061846 | Combi SCAN100 | 2007 | 0 |
| K061812 | Combi Scan 500 Urine Test Strip Analyzer, Model A93005 | 2007 | 0 |
| K051034 | Uryxxon 200 Urine Analyzer | 2005 | 0 |
| K032437 | Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD Test Strips | 2003 | 0 |
| K022386 | Pocketchem UA Aution Sticks 10TA | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2004 | Not classified | Z-1051-04 | Other | Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications. |
| Jun 19, 2003 | Not classified | Z-0911-03 | Other | Analyzer will produce erroneous results due to missing grounding strap. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031947 (Bayer Healthcare, LLC, 2003) has gone furthest, with 16 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 | — |
What is it indicated for?
The CLINITEK 50 Urine Chemistry Analyzer is for use with Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color. The tests provided on Bayer Reagent Strips and urine color are considered routine urinalysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960546: Clinitek 50 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/K960546
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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