510(k) · Cleared
ClearedVortek Hydro-Coated Double Loop Ureteral Stents
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 15, 2017 as substantially equivalent to K881744 (Bivona Medical Technologies, 1988) and 1 other predicate after a 282-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Nov 15, 2017
- Review
- 282 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881744 (1988). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881744 Porges Ureteral StentBivona Medical Technologies · 1988
- This deviceK170362 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 · 2 generations on · 0 of its ownK213186 NovoFlow Reinforced Ureteral StentColoplast Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK201436 Vortek Single Loop Ureteral StentColoplast Corp. · 2021
- Descendant · cites it directly · 0 of its ownK180469 ImaJin Silicone Hydro-Coated Double Loop Ureteral StentColoplast Corp. · 2018
Most influential descendants
Showing 4 of 4 · See all- K180057Vortek Ureteral Double Loop StentColoplast Corp. · 2018 · cites it directly2descendants
- K213186NovoFlow Reinforced Ureteral StentColoplast Corp. · 2022 · 2 generations on0descendants
- K201436Vortek Single Loop Ureteral StentColoplast Corp. · 2021 · 2 generations on0descendants
- K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentColoplast Corp. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881744 | Porges Ureteral Stent | Bivona Medical Technologies | 1988 | — |
| 0 (this device) | K170362 | Vortek Hydro-Coated Double Loop Ureteral Stents | Coloplast Corp. | 2017 | — |
| +1 | K180057 | Vortek Ureteral Double Loop Stent | Coloplast Corp. | 2018 | — |
| +2 | K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022 | — |
| +2 | K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K881744 | Porges Ureteral StentSummary page 4…ssories are substantially equivalent in performance, indication, design and materials to Vortek Ureteral Double Loop Stents, cleared under premarket notification numbers K881744 and K981591. Device Description: The Vortek Hydro-Coated Double loop ureteral stents are flexible tubular devices supplied with… | 1988 |
| * | K981591 | Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentSummary page 4…substantially equivalent in performance, indication, design and materials to Vortek Ureteral Double Loop Stents, cleared under premarket notification numbers K881744 and K981591. Device Description: The Vortek Hydro-Coated Double loop ureteral stents are flexible tubular devices supplied with a hydrogel… | 1998 |
What descends from it? (4)
2 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?
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170362: Vortek Hydro-Coated Double Loop Ureteral Stents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170362
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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