510(k) · Cleared
ClearedPorges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porges S.A. · FAD Stent, Ureteral
Cleared on Oct 17, 2002 as substantially equivalent to K881744 (Bivona Medical Technologies, 1988) and 1 other predicate after a 324-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Oct 17, 2002
- Review
- 324 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881744 (1988). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881744 Porges Ureteral StentBivona Medical Technologies · 1988
- This deviceK013921 Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XPorges S.A. · 2002
- Descendant · cites it directly · 0 of its ownK213185 ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent…Coloplast Corp. · 2022
- Descendant · cites it directly · 0 of its ownK180469 ImaJin Silicone Hydro-Coated Double Loop Ureteral StentColoplast Corp. · 2018
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 |
|---|---|---|---|---|---|
| −1 | K881744 | Porges Ureteral Stent | Bivona Medical Technologies | 1988 | — |
| 0 (this device) | K013921 | Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X | Porges S.A. | 2002 | — |
| +1 | K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone… | Coloplast Corp. | 2022 | — |
| +1 | K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | 2018 | — |
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 |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K881744 | Porges Ureteral StentSummary page 1…with a clamp) 5.5. Intended use of the Device The PORGES" Silicone double loop ureteral stent is intended for the exact same use as the current PORGES ureteral stent (K881744) and VORTEK" and BIOSOFT" ureteral double loop stents (K981591). The PORGESTMSilicone double loop ureteral stent is used for : St… | 1988 |
| * | K981591 | Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop StentSummary page 1…licone double loop ureteral stent is intended for the exact same use as the current PORGES ureteral stent (K881744) and VORTEK" and BIOSOFT" ureteral double loop stents (K981591). The PORGESTMSilicone double loop ureteral stent is used for : Standard versions Drainage of the upper urinary tract… | 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?
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?
Standard versions
Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.9. periureteral tumour)
Cicatrisation stent
Reinforced versions
Management of ureteral stenoses
Partial enlargement of the diameter: localised stenoses connected with ureteropelvic junction syndrome
Total enlargement of the diameter: stenoses over all or part of the ureter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013921: Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013921
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026