510(k) · Cleared
ClearedUriscan S-300 Semi-Automated Urine Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yeongdong Pharmaceutical Corp. · KQO Automated Urinalysis System
Cleared on Jun 10, 1998 as substantially equivalent to K842237 (Miles Laboratories, Inc., 1984) and 1 other predicate after a 155-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jun 10, 1998
- Review
- 155 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K842237 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK842237 Clinitek 200 Semi-Automated UrinalysisMiles Laboratories, Inc. · 1984
- This deviceK980047 Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842237 | Clinitek 200 Semi-Automated Urinalysis | Miles Laboratories, Inc. | 1984 | — |
| 0 (this device) | K980047 | Uriscan S-300 Semi-Automated Urine Chemistry Analyzer | Yeongdong Pharmaceutical Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K842237 | Clinitek 200 Semi-Automated UrinalysisSummary page 2…substantially equivalent for purposes of Section 510(k) of the Federal Food, Drug and Cosmetic Act to the Ames/Miles, Inc. Clinitek 200 Semi-automated Urinalysis System (K842237), and the Boehringer Mannheim (Hitachi) Miditron Urine Analyzer system (K934042) in significant features, materials and intended… | 1984 |
| * | K934042 | Chemstrip Super UA Urine AnalyzerSummary page 2…g and Cosmetic Act to the Ames/Miles, Inc. Clinitek 200 Semi-automated Urinalysis System (K842237), and the Boehringer Mannheim (Hitachi) Miditron Urine Analyzer system (K934042) in significant features, materials and intended use. 5. Description of the Subject Device: The URISCAN S-300 Semi-Automated Ur… | 1993 |
| * | — | Boehringer Mannheim Chemstrip Super UA 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?
- None of the 2 ancestors has a recall.
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 URISCAN S-300 Semi-Automated Urine Chemistry Analyzer is a urine analyzer for detection of Occult Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Glucose, pH, Specific Gravity, Leukocytes and Ascorbi Acid in urine specimens through the reflectance method.
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/K980047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980047: Uriscan S-300 Semi-Automated Urine Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980047
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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