510(k) · Cleared
Recalled · Class II · 2023Urinalysis Reagent Strips (10 Parameters)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Newtech Development, Inc. · JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Cleared on Jan 3, 2000 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 3, 2000
- Review
- 52 days
- Class
- Class I
- Product code
- JMT
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK993850 Urinalysis Reagent Strips (10 Parameters)International Newtech Development, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK040703 Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK082811 Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and…Urit Medical Electronic Co., Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK111999 Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip…Healgen Scientific,, LLC · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K040703Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd. · 2004 · cites it directly3descendants
- K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 2009 · 2 generations on1descendant
- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · 3 generations on0descendants
- K111999Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and…Healgen Scientific,, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993850 | Urinalysis Reagent Strips (10 Parameters) | International Newtech Development, Inc. | 2000 | — |
| +1 | K040703 | Uristik H Series Reagent Strips for Urinalysis | Dirui Industrial Co., Ltd. | 2004 | — |
| +2 | K082811 | Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine… | Urit Medical Electronic Co., Ltd. | 2009 | — |
| +3 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
| +2 | K111999 | Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for… | Healgen Scientific,, LLC | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K040703 | Uristik H Series Reagent Strips for Urinalysis | 2004 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2023 | Class II | Z-0044-2024 | Other | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing… |
| May 22, 2023 | Class II | Z-0057-2024 | Other | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040703 (Dirui Industrial Co., Ltd., 2004) has gone furthest, with 3 descendants of its own.
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.
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?
Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993850: Urinalysis Reagent Strips (10 Parameters).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993850
Report an extraction error
Are you the manufacturer?
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