510(k) · Cleared
ClearedTeco Diagnostics Uti Detection Strips
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 Feb 17, 2011 as substantially equivalent to K905396 (Heraeus Kulzer, Inc., 1991) after a 408-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 408 days
- Class
- Class I
- Product code
- JMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905396 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- This deviceK100024 Teco Diagnostics Uti Detection StripsTeco Diagnostics · 2011
- Descendant · cites it directly · 3 of its ownK231045 Healgen URS Test StripsHealgen Scientific,, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK251800 Healgen® URS Test StripsHealgen Scientific,, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK252607 AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242767 Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K231045Healgen URS Test StripsHealgen Scientific,, LLC · 2023 · cites it directly3descendants
- K251800Healgen® URS Test StripsHealgen Scientific,, LLC · 2025 · 2 generations on0descendants
- K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd. · 2025 · 2 generations on0descendants
- K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| 0 (this device) | K100024 | Teco Diagnostics Uti Detection Strips | Teco Diagnostics | 2011 | — |
| +1 | K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023 | — |
| +2 | K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025 | — |
| +2 | K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +2 | K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | K905396 | Hemastix Reagent StripsSummary page 2…-1169 10 www.tecodiagl.com Predicate Device: Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA. Device Description: Teco Diagnostics UTI T… | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231045 | Healgen URS Test Strips | 2023 | 3 |
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?
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. 2011, 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 Teco Diagnostics UTI Test Strips are intended for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100024: Teco Diagnostics Uti Detection Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100024
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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