510(k) · Cleared
ClearedSafecare Urinary Tract Infection Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safecare Biotech (Hangzhou) Co., Ltd. · JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Cleared on Jan 10, 2025 as substantially equivalent to K231045 (Healgen Scientific,, LLC, 2023) after a 119-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jan 10, 2025
- Review
- 119 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 deviceK242767 Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd. · 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) | K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | 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 K251800 Healgen® URS Test Stripsscore 11.2 · 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…1510 Product Code(s) JMT, LJX I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231045 Healgen URS Test Strips LJX Device Description Summary 21 CFR 807.92(a)(4) Urinary Tract Infection Test is in vitro diagnostic t… | 2023 |
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 4 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 Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.
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/K242767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242767: Safecare Urinary Tract Infection Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242767
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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