510(k) · Cleared
ClearedVortek Single 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 Feb 25, 2021 as substantially equivalent to K924608 (Boston Scientific Corp, 1994) and 1 other predicate after a 269-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Feb 25, 2021
- Review
- 269 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K881744 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK881744 Porges Ureteral StentBivona Medical Technologies · 1988
- 2 generations backK170362 Vortek Hydro-Coated Double Loop Ureteral StentsColoplast Corp. · 2017
- 1 generation backK180057 Vortek Ureteral Double Loop StentColoplast Corp. · 2018
- This deviceK201436 Vortek Single Loop Ureteral StentColoplast Corp. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881744 | Porges Ureteral Stent | Bivona Medical Technologies | 1988 | — |
| −2 | K170362 | Vortek Hydro-Coated Double Loop Ureteral Stents | Coloplast Corp. | 2017 | — |
| −1 | K180057 | Vortek Ureteral Double Loop Stent | Coloplast Corp. | 2018 | — |
| 0 (this device) | K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K924608 | Hydrogel Coated Percuflex (R) Drainage CathetersSummary page 4…eteral) Advisory Panel: Gastroenterology/Urology III. PREDICATE DEVICE Primary predicate: Hydrogel Coated Percuflex® Drainage Catheters (K924608) Secondary predicate: Vortek® Double Loop Ureteral Stents (K180057) These predicates have not been subject to a design-related… | 1994 |
| * | K180057 | Vortek Ureteral Double Loop StentSummary page 4…logy III. PREDICATE DEVICE Primary predicate: Hydrogel Coated Percuflex® Drainage Catheters (K924608) Secondary predicate: Vortek® Double Loop Ureteral Stents (K180057) These predicates have not been subject to a design-related recall. Page 5-1 ===… | 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 33 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- 7 other devices also cite its predicate K924608.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Surgical indication:
The Vortek® Single Loop Ureteral Stent is intended for use in ureterostomy or vesical replacement in adult and pediatric (adolescents, children, and infants) patients requiring endourological procedure and /or short-term (less than 30 days) drainage of the upper urinary tract.
Endoscopic indication:
The Vortek® Single Loop Ureteral Stent is intended for short-term (less than 30 days) drainage of urine from the upper urinary tract over fistulas or ureteral obstacles in adult and pediatric (adolescents, children, and infants) patients.
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/K201436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201436: Vortek Single Loop Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201436
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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