510(k) · Cleared
ClearedHealgen® URS Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Cleared on Dec 23, 2025 as substantially equivalent to K231045 (Healgen Scientific,, LLC, 2023) after a 194-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Dec 23, 2025
- Review
- 194 days
- Class
- Class I
- Product code
- JMT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905396 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 2 generations backK100024 Teco Diagnostics Uti Detection StripsTeco Diagnostics · 2011
- 1 generation backK231045 Healgen URS Test StripsHealgen Scientific,, LLC · 2023
- This deviceK251800 Healgen® URS Test StripsHealgen Scientific,, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −2 | K100024 | Teco Diagnostics Uti Detection Strips | Teco Diagnostics | 2011 | — |
| −1 | K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023 | — |
| 0 (this device) | K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025 | — |
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 K252607 AllTest Urinary Tract Infection Testscore 10.9 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K231045 | Healgen URS Test StripsSummary page 5…se Test System Hematology JMT 21 CFR § 862.1510, Nitrite Test System Clinical Chemistry 5. Predicate Devices: K231045 Healgen URS Test Strips 6. Intended Use: The Healgen® URS Test Strips are for the qualitative dete… | 2023 |
| † | K111999 | Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and… | 2012 |
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K231045.
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. 2025, 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 Healgen® URS Test Strips are for the qualitative detection of leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a 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/K251800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251800: Healgen® URS Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251800
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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