510(k) · Cleared
ClearedDD Ureteral Stent, Integral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · FAD Stent, Ureteral
Cleared on Jul 2, 1999 after a 311-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 2, 1999
- Review
- 311 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK982974 DD Ureteral Stent, Integral StentRusch Intl. · 1999
- Descendant · cites it directly · 3 of its ownK033210 Bioteq Double Pigtail Ureteral Stent SetBioteque Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK162104 C-Flex Ureteral Stent SetCook Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK180053 Sof-Flex Ureteral Stent SetCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK063742 Resonance Metallic Ureteral StentCook Ireland, Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K033210Bioteq Double Pigtail Ureteral Stent SetBioteque Corp. · 2004 · cites it directly3descendants
- K162104C-Flex Ureteral Stent SetCook Incorporated · 2017 · 2 generations on1descendant
- K180053Sof-Flex Ureteral Stent SetCook Incorporated · 2018 · 3 generations on0descendants
- K063742Resonance Metallic Ureteral StentCook Ireland, Ltd. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982974 | DD Ureteral Stent, Integral Stent | Rusch Intl. | 1999 | — |
| +1 | K033210 | Bioteq Double Pigtail Ureteral Stent Set | Bioteque Corp. | 2004 | — |
| +2 | K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017 | — |
| +3 | K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | 2018 | — |
| +2 | K063742 | Resonance Metallic Ureteral Stent | Cook Ireland, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (6)
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 |
|---|---|---|---|
| * | — | Microvasive Boston Scientific Corporation, Mardis Stent Set with guidewire Named without a submission number | |
| * | — | Surgitek, Cabot Medical Corporation, available with and without guidewire Named without a submission number | |
| * | — | Mentor filiform ureteral double pigtail silicone stent Named without a submission number | |
| * | — | Cook Double Pigtail Standard and AQ Stent Sets Named without a submission number | |
| * | — | American Catheter Amcath Uroglide Stent Named without a submission number | |
| * | — | Microvasive Hydro-Plus Coated Marquis-stent Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033210 | Bioteq Double Pigtail Ureteral Stent Set | 2004 | 3 |
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, K033210 (Bioteque Corp., 2004) has gone furthest, with 3 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?
Risch ureter stents are intended for use in temporary internal
drainage from the kidney to the bladder or other external
collecting location.
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/K982974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982974: DD Ureteral Stent, Integral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982974
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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