510(k) · Cleared
ClearedTC-Thunderbolt Automated Urine Analyzer System and TC-Thunderbolt Urs-10 Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Jul 24, 2015 as substantially equivalent to K051526 (Teco Diagnostics, 2005) after a 431-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jul 24, 2015
- Review
- 431 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051526 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK051526 Uritek-720+ Urine AnalyzerTeco Diagnostics · 2005
- This deviceK141289 TC-Thunderbolt Automated Urine Analyzer System and TC-Thunderbolt…Teco Diagnostics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051526 | Uritek-720+ Urine Analyzer | Teco Diagnostics | 2005 | — |
| 0 (this device) | K141289 | TC-Thunderbolt Automated Urine Analyzer System and TC-Thunderbolt Urs-10 Strips | Teco Diagnostics | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K051526 | Uritek-720+ Urine AnalyzerSummary page 5…4‐1 4.4) Predicate Device: Uritek-720+ Urine Analyzer for the use with Teco Diagnostic’s URS-10 strips (k051526). 4.5) Description of the proposed device: The proposed device is an automated urine chemistry analyzer system intended for use… | 2005 |
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 JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for…
Read the full statement (102 words)
The TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine
chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH,
bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are
intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual
reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are
used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
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/K141289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141289: TC-Thunderbolt Automated Urine Analyzer System and TC-Thunderbolt Urs-10 Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141289
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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