510(k) · Cleared
ClearedImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · FAD Stent, Ureteral
Cleared on Nov 6, 2018 as substantially equivalent to K013921 (Porges S.A., 2002) and 1 other predicate after a 258-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Nov 6, 2018
- Review
- 258 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K881744 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881744 | Porges Ureteral Stent | Bivona Medical Technologies | 1988 | — |
| −1 | K013921 | Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X | Porges S.A. | 2002 | — |
| 0 (this device) | K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2017 | 1 | 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 FAD? 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 FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K013921 | Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XSummary page 4…performance, indication, design and materials to the primary predicate device, Porges™ Silicone Double Loop Ureteral Stents, cleared under premarket notification number K013921. In addition to the primary predicate, the Vortek® Hydro-coated Double Loop Ureteral Stent, cleared under premarket notification… | 2002 |
| * | K170362 | Vortek Hydro-Coated Double Loop Ureteral StentsSummary page 4…rket notification number K013921. In addition to the primary predicate, the Vortek® Hydro-coated Double Loop Ureteral Stent, cleared under premarket notification number K170362, is a secondary predicate for this submission. The Vortek Hydro-coated Double Loop Ureteral Stent has the same intended use but i… | 2017 |
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 30 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K013921.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, 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 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Silicone Hydro-Coated Double Loop Ureteral Stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180469: ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180469
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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