510(k) · Cleared
Recalled · Class II · 2020Universa Soft Ureteral Stents and Stent Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FAD Stent, Ureteral
Cleared on Jan 11, 2016 as substantially equivalent to K961446 (Cook Urological, Inc., 1996) and 1 other predicate after a 266-day review. Its family tree reaches back 4 generations to 1991. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 11, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903345 (1991). 6 ancestors in all, the oldest K905289 (1991). 11 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 3 generations backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- 2 generations backK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- 1 generation backK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · Recalled
- This deviceK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016
- Descendant · cites it directly · 5 of its ownK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK213444 RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF…Ureteral Stent Company · 2022
- Descendant · cites it directly · 1 of its ownK173734 RocaJJ Soft StentsPromepla Sam · 2018
- Descendant · cites it directly · 1 of its ownK162104 C-Flex Ureteral Stent SetCook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK251890 Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K161236Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · cites it directly5descendants
- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…Ureteral Stent Company · 2022 · 2 generations on2descendants
- K173734RocaJJ Soft StentsPromepla Sam · 2018 · cites it directly1descendant
- K162104C-Flex Ureteral Stent SetCook Incorporated · 2017 · cites it directly1descendant
- K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −3 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| −2 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| −1 | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | 6 |
| 0 (this device) | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | — |
| +1 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| +2 | K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… | Ureteral Stent Company | 2022 | — |
| +1 | K173734 | RocaJJ Soft Stents | Promepla Sam | 2018 | — |
| +1 | K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017 | — |
| +2 | K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K961446 | AQ Hydrophilic StentSummary page 4…0281 Universa Soft Ureteral Stents and Stent Sets Stent, Ureteral Class II 21 CFR § 876.4620 Gastroenterology/Urology Devices FAD AQ Hydrophilic Stents (Cook Inc., K961446) Bard® InLayOptima" Ureteral Stent with Suture (C. R. Bard, Inc., K043193) 3. Comparison to Predicate: The technological charac… | 1996 |
| * | K043193 | Bard Inlayoptima Ureteral Stent with SutureSummary page 4…II 21 CFR § 876.4620 Gastroenterology/Urology Devices FAD AQ Hydrophilic Stents (Cook Inc., K961446) Bard® InLayOptima" Ureteral Stent with Suture (C. R. Bard, Inc., K043193) 3. Comparison to Predicate: The technological characteristics of the Universa Soft Ureteral Stents and Stent Sets are substa… | 2004 |
What descends from it? (11)
See all 115 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2020 | Class II | Z-2971-2020 | Under Investigation by firm | Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product. |
| Jan 4, 2019 | Class II | Z-0978-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K161236 (Cook Incorporated, 2017) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K961446.
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?
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, percutaneous, or open surgical techniques.
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/K151051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151051: Universa Soft Ureteral Stents and Stent Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151051
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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