510(k) · Cleared
ClearedBioteq Double Pigtail Ureteral Stent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteque Corp. · FAD Stent, Ureteral
Cleared on Dec 30, 2004 as substantially equivalent to K982974 (Rusch Intl., 1999) after a 454-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Dec 30, 2004
- Review
- 454 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982974 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982974 DD Ureteral Stent, Integral StentRusch Intl. · 1999
- This deviceK033210 Bioteq Double Pigtail Ureteral Stent SetBioteque Corp. · 2004
- Descendant · cites it directly · 1 of its ownK162104 C-Flex Ureteral Stent SetCook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK180053 Sof-Flex Ureteral Stent SetCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK063742 Resonance Metallic Ureteral StentCook Ireland, Ltd. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982974 | DD Ureteral Stent, Integral Stent | Rusch Intl. | 1999 | — |
| 0 (this device) | K033210 | Bioteq Double Pigtail Ureteral Stent Set | Bioteque Corp. | 2004 | — |
| +1 | K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017 | — |
| +2 | K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | 2018 | — |
| +1 | K063742 | Resonance Metallic Ureteral Stent | Cook Ireland, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K982974 | DD Ureteral Stent, Integral StentSummary page 1…Stent 3. Classification: Class II Predicate Device: Rusch Ureter Stent Integral Set and Rusch Ureter DOD Stent Sets (K982974) marketed by RUSCH INTL. 5. Device Description: The BIOTEO® DOUBLE PIGTAIL URETERAL STENT SET consist of… | 1999 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K162104 (Cook Incorporated, 2017) has gone furthest, with 1 descendant 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?
BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033210 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033210: Bioteq Double Pigtail Ureteral Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033210
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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