510(k) · Decided
DecidedImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · FAD Stent, Ureteral
Cleared on Jun 8, 2022 as substantially equivalent to K013921 (Porges S.A., 2002) after a 252-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jun 8, 2022
- Review
- 252 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881744 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK881744 Porges Ureteral StentBivona Medical Technologies · 1988
- 1 generation backK013921 Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XPorges S.A. · 2002
- This deviceK213185 ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent…Coloplast Corp. · 2022
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) | K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone… | Coloplast Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 |
|---|---|---|---|
| * | K013921 | Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XSummary page 4…D Regulatory Class: 2 III. PREDICATE AND REFERENCE DEVICES Predicate Device: Porges™ Silicone Double Loop Ureteral Stents, K013921 Reference Device: Silicone Hydro-coated double loop ureteral stent, K180469 The predicate and reference dev… | 2002 |
| † | K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | 2018 |
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 19.6 years on median.
- None of the 3 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. 2022, 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?
Silicone double loop ureteral stents: The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months. Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management…
Read the full statement (138 words)
Silicone double loop ureteral stents:
The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.
Pyelostent and Stenostent Silicone double loop ureteral stents:
Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:
For Pyelostent® Silicone double loop ureteral stents:
Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.
For Stenostent® Silicone double loop ureteral stents:
Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.
The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213185: ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213185
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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