510(k) · Cleared
ClearedpAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q Urological Corporation · FAD Stent, Ureteral
Cleared on Dec 22, 2016 as substantially equivalent to K082805 (Q Urological Corporation, 2010) after a 50-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- Dec 22, 2016
- Review
- 50 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082805 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK082805 Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model…Q Urological Corporation · 2010
- This deviceK163068 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation · 2016
- Descendant · cites it directly · 0 of its ownK172289 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082805 | Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXX | Q Urological Corporation | 2010 | — |
| 0 (this device) | K163068 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2016 | — |
| +1 | K172289 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K082805 | Paguamedicina Structural Hydrogel Pediatric Ureteral Stent, Model NP330-XXXSummary page 5…of ureteral injuries and ureteral obstruction” (21 CFR 876.4620). The purpose of this Special 510(k) is to expand the product line of a 4 French ureteral stent [510(k) K082805] to add stents in sizes 5, 6, 7 and 8 French. The recommended usage of the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Uretera… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172289 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | 2017 | 0 |
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, K172289 (Q Urological Corporation, 2017) has gone furthest, with 0 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. 2016, 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 pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopes, percutaneous, or open surgical techniques. The Stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163068: pAguaMedicina PERSISTENT Structural Hydrogel 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/K163068
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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