510(k) · Cleared
ClearedUryxxon 200 Urine Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macherey-Nagel GmbH & Co. KG · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Nov 22, 2005 as substantially equivalent to K960546 (Bayer Corp., 1996) after a 214-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 22, 2005
- Review
- 214 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960546 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960546 Clinitek 50 Urine Chemistry AnalyzerBayer Corp. · 1996 · Recalled
- This deviceK051034 Uryxxon 200 Urine AnalyzerMacherey-Nagel GmbH & Co. KG · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960546 | Clinitek 50 Urine Chemistry Analyzer | Bayer Corp. | 1996 | 2 |
| 0 (this device) | K051034 | Uryxxon 200 Urine Analyzer | Macherey-Nagel GmbH & Co. KG | 2005 | — |
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 JIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K960546 | Clinitek 50 Urine Chemistry AnalyzerSummary page 1…3) Predicate device We claim substantial equivalence to the currently market CLINITE0a50 Urine Analyzer, manufactured by Bayer Corp. (K960546). 4) Device Description The URYXXON® 200 Urine Analyzer is a reflectance photometer for in- vitr… | 1996 |
| * | — | URYSIS 1100 Urine Analyzer Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K960546.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, 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 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The URYXXON® 200 is a portable reflectance photometer that instrumentally measures the reflectance off a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The product is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes, metabolic abnormalities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract.
The test provided on Macherey-Nagel Reagent Strips for the determination of specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051034 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051034: Uryxxon 200 Urine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051034
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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