510(k) · Cleared
ClearedVortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Regulatory Consultants · FAD Stent, Ureteral
Cleared on Oct 9, 1998 after a 158-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Oct 9, 1998
- Review
- 158 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK981591 Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentInternational Regulatory Consultants · 1998
- Descendant · cites it directly · 4 of its ownK170362 Vortek Hydro-Coated Double Loop Ureteral StentsColoplast Corp. · 2017
- Descendant · cites it directly · 2 of its ownK180057 Vortek Ureteral Double Loop StentColoplast Corp. · 2018
- Descendant · cites it directly · 2 of its ownK013921 Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XPorges S.A. · 2002
- Descendant · 2 generations on · 0 of its ownK213185 ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent…Coloplast Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK213186 NovoFlow Reinforced Ureteral StentColoplast Corp. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170362Vortek Hydro-Coated Double Loop Ureteral StentsColoplast Corp. · 2017 · cites it directly4descendants
- K180057Vortek Ureteral Double Loop StentColoplast Corp. · 2018 · cites it directly2descendants
- K013921Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XPorges S.A. · 2002 · cites it directly2descendants
- K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…Coloplast Corp. · 2022 · 2 generations on0descendants
- K213186NovoFlow Reinforced Ureteral StentColoplast Corp. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981591 | Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent | International Regulatory Consultants | 1998 | — |
| +1 | K170362 | Vortek Hydro-Coated Double Loop Ureteral Stents | Coloplast Corp. | 2017 | — |
| +1 | K180057 | Vortek Ureteral Double Loop Stent | Coloplast Corp. | 2018 | — |
| +1 | K013921 | Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X | Porges S.A. | 2002 | — |
| +2 | K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone… | Coloplast Corp. | 2022 | — |
| +2 | K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K170362 (Coloplast Corp., 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The “flush” ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.
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/K981591 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981591
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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