510(k) · Cleared
ClearedVortek Ureteral Double Loop 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 Mar 9, 2018 as substantially equivalent to K170362 (Coloplast Corp., 2017) and 2 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Mar 9, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K881744 (1988). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK881744 Porges Ureteral StentBivona Medical Technologies · 1988
- 1 generation backK170362 Vortek Hydro-Coated Double Loop Ureteral StentsColoplast Corp. · 2017
- This deviceK180057 Vortek Ureteral Double Loop StentColoplast Corp. · 2018
- Descendant · cites it directly · 0 of its ownK213186 NovoFlow Reinforced Ureteral StentColoplast Corp. · 2022
- Descendant · cites it directly · 0 of its ownK201436 Vortek Single Loop Ureteral StentColoplast Corp. · 2021
Most influential descendants
Showing 2 of 2 · See allView 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 | K170362 | Vortek Hydro-Coated Double Loop Ureteral Stents | Coloplast Corp. | 2017 | — |
| 0 (this device) | K180057 | Vortek Ureteral Double Loop Stent | Coloplast Corp. | 2018 | — |
| +1 | K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022 | — |
| +1 | K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K170362 | Vortek Hydro-Coated Double Loop Ureteral StentsSummary page 4…Product Code: FAD Device Class: 2 III. PREDICATE DEVICE Vortek® Hydro-Coated Double Loop Ureteral Stents (K170362) and Vortek® Double Loop Ureteral Stents (K881744 and K981591). This predicate has not been subject to a design-related recall.… | 2017 |
| * | K881744 | Porges Ureteral StentSummary page 4…Device Class: 2 III. PREDICATE DEVICE Vortek® Hydro-Coated Double Loop Ureteral Stents (K170362) and Vortek® Double Loop Ureteral Stents (K881744 and K981591). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 1988 |
| * | K981591 | Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentSummary page 4…Device Class: 2 III. PREDICATE DEVICE Vortek® Hydro-Coated Double Loop Ureteral Stents (K170362) and Vortek® Double Loop Ureteral Stents (K881744 and K981591). This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEV… | 1998 |
What descends from it? (2)
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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 29.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213186 (Coloplast Corp., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170362.
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 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/K180057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180057: Vortek Ureteral Double Loop Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180057
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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