510(k) · Cleared
ClearedUrs-1B (Blood Test)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · JIO Blood, Occult, Colorimetric, In Urine
Cleared on Mar 6, 2003 after a 155-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 6, 2003
- Review
- 155 days
- Class
- Class II
- Product code
- JIO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIO? 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 JIO device
- #1 K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA…score 8.4 · 5 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JIO devicesJIO Blood, Occult, Colorimetric, In Urine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JIO
Too few JIO 510(k)s in any year since 2007 to give a median.
Recalls per year · JIO
No recall names JIO since 2007.
Adverse event reports per year · JIO
1in 2025
MAUDE reports naming product code JIO, 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 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TECO Diagnostics URS-1B (Blood Test) is intended for “Professional Use.” The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023297: Urs-1B (Blood Test).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023297
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026