510(k) · Cleared
ClearedUriscan Optima
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yd Diagnostics Corp. · KQO Automated Urinalysis System
Cleared on May 28, 2015 as substantially equivalent to K091216 (Siemens Healthcare Diagnostics, 2009) after a 321-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- May 28, 2015
- Review
- 321 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905396 (1991). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 2 generations backK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- This deviceK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
- Descendant · cites it directly · 1 of its ownK210069 Minuteful - kidney testHealthy.Io, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK222921 Minuteful-kidney testHealthy.Io, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −2 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| 0 (this device) | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
| +1 | K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022 | — |
| +2 | K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Summary page 4…JIR (protein or albumin) JFY (creatinine) KQO (Automated urinalysis system) Predicate Device Information: K091216 Clinitek Status (Siemens) Device Description: URiSCAN Optima – the semi-quantitative urine analyzer is used with the aim of help… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210069 | Minuteful - kidney test | 2022 | 1 |
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K210069 (Healthy.Io, Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K091216.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results. The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters; Albumin Creatinine ACR (Albumin…
Read the full statement (110 words)
The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results.
The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters;
Albumin
Creatinine
ACR (Albumin Creatinine Ratio)
These measurements are useful in the evaluation of renal, urinary and metabolic disorders. URiSCAN Optima urine chemistry test system is intended for prescription use only, in clinical laboratory and in point-of-care setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141874: Uriscan Optima.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141874
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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