510(k) · Cleared
ClearedDipstreak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novamed, Ltd. · JSI Culture Media, Selective And Differential
Cleared on Jul 30, 1998 as substantially equivalent to K921045 (Savyon Diagnostics, Ltd., 1992) after a 248-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 30, 1998
- Review
- 248 days
- Class
- Class I
- Product code
- JSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921045 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921045 Diaslide Urine Culturing DeviceSavyon Diagnostics, Ltd. · 1992
- This deviceK974428 DipstreakNovamed, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921045 | Diaslide Urine Culturing Device | Savyon Diagnostics, Ltd. | 1992 | — |
| 0 (this device) | K974428 | Dipstreak | Novamed, Ltd. | 1998 | — |
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 JSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K921045 | Diaslide Urine Culturing DeviceSummary page 1…vised) ary 1. Name of device: DipStreak Urine Culture Device (K974428) 2. Identification of the predicate device: the Savyon Diaslide Urine Culturing Device (510(k) no. K921045). 3. Description of the device: DipStreak comprises a plastic paddle with two types of agar attached back-to-back, housed in a c… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JSI devicesJSI Culture Media, Selective And Differential: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JSI
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · JSI
Too few JSI 510(k)s in any year since 2007 to give a median.
Recalls per year · JSI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSI
42in 2025
MAUDE reports naming product code JSI, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 83 |
| 2022 | 0 | — | 2 | 88 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 22 |
| 2025 | 0 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.
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/K974428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974428: Dipstreak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974428
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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