510(k) · Cleared
ClearedRocaJJ Soft Stents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promepla Sam · FAD Stent, Ureteral
Cleared on Mar 12, 2018 as substantially equivalent to K043193 (C.R. Bard, Inc., 2004) and 1 other predicate after a 96-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Mar 12, 2018
- Review
- 96 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903345 (1991). 7 ancestors in all, the oldest K905289 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 4 generations backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- 3 generations backK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- 2 generations backK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · Recalled
- 1 generation backK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- This deviceK173734 RocaJJ Soft StentsPromepla Sam · 2018
- Descendant · cites it directly · 0 of its ownK212868 JFil Ureteral Stents, JFil Ureteral Stents ECO KITRocamed Sam · 2022
Most influential descendants
Showing 1 of 1 · See all- K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KITRocamed Sam · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −4 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| −3 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| −2 | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | 6 |
| −1 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| 0 (this device) | K173734 | RocaJJ Soft Stents | Promepla Sam | 2018 | — |
| +1 | K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K043193 | Bard Inlayoptima Ureteral Stent with SutureSummary page 4…Product name Manufacturer 510(k) number 1 Bard InLayOptima Ureteral Stent Bard K043193 With Suture 2 Universa Soft Ureteral Stents and Cook K151… | 2004 |
| * | K151051 | Universa Soft Ureteral Stents and Stent SetsSummary page 4…Bard K043193 With Suture 2 Universa Soft Ureteral Stents and Cook K151051 Stent Sets Section 5 CONFIDENTIAL… | 2016 |
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 |
|---|---|---|---|
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | 2022 | 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K212868 (Rocamed Sam, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K043193.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 RocaJJ Soft Stents are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic techniques.
The stents are not intended as a permanent indwelling devices, it is recommended that:
- The indwelling time not exceed 6 days when the device is used with the removal string;
- The indwelling time not exceed 365 days when the device is used without the removal string.
Target population: adults only (at least 22 years old)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173734: RocaJJ Soft Stents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173734
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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