510(k) · Cleared
ClearedScanostics UTI Check Application Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Cleared on Sep 21, 2017 as substantially equivalent to K970250 (Teco Diagnostics, 1997) after a 251-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 21, 2017
- Review
- 251 days
- Class
- Class I
- Product code
- JMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970250 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970250 ClinistripTeco Diagnostics · 1997
- This deviceK170118 Scanostics UTI Check Application Test SystemTeco Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970250 | Clinistrip | Teco Diagnostics | 1997 | — |
| 0 (this device) | K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | 2017 | — |
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 JMT? 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 JMT device
- #1 K251800 Healgen® URS Test Stripsscore 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K970250 | ClinistripSummary page 6…877140, 8911679 and 8506901). J. Substantial Equivalence Information: 1. Predicate device name(s): Clinistrip 10SGL 2. Predicate K number(s) k970250 3. Compare with predicate: Table 5.1 Scanostics UTI Check Application vs Clinistrip… | 1997 |
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 no recall.
How does its category compare?
All JMT devicesJMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JMT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JMT
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JMT
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMT
2in 2020
MAUDE reports naming product code JMT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 119 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L
(UTD) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an
aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.
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/K170118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170118: Scanostics UTI Check Application 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/K170118
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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