510(k) · Cleared
Recalled · Class II · 2020Universa Firm 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 27, 2017 as substantially equivalent to K151051 (Cook Incorporated, 2016) and 1 other predicate after a 270-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 2017
- Review
- 270 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903345 (1991). 7 ancestors in all, the oldest K905289 (1991). 5 later devices descend from it, 3 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 deviceK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017
- Descendant · cites it directly · 2 of its ownK213444 RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF…Ureteral Stent Company · 2022
- Descendant · cites it directly · 0 of its ownK251890 Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243830 Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK232920 RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™…Ureteral Stent Company · 2024
- Descendant · cites it directly · 0 of its ownK172017 Black Silicone Filiform Double Pigtail Stent SetCook Incorporated · 2018
Most influential descendants
Showing 5 of 5 · See all- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…Ureteral Stent Company · 2022 · cites it directly2descendants
- K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit…Ureteral Stent Company · 2024 · 2 generations on0descendants
- K172017Black Silicone Filiform Double Pigtail Stent SetCook Incorporated · 2018 · 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) | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | — |
| +1 | K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… | Ureteral Stent Company | 2022 | — |
| +1 | K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
| +2 | K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | 2025 | — |
| +2 | K232920 | RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral… | Ureteral Stent Company | 2024 | — |
| +1 | K172017 | Black Silicone Filiform Double Pigtail Stent Set | Cook Incorporated | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K151051 | Universa Soft Ureteral Stents and Stent SetsSummary page 4…troenterology/Urology Devices Predicate Device: The predicate devices are: • Universa® Soft Ureteral Stents and Stent Sets cleared under 510(k) К151051 on January 11, 2016 • Bard® InLayOptima™ Ureteral Stent with Suture cleared under 51 O(k) КО43 193 on… | 2016 |
| * | K043193 | Bard Inlayoptima Ureteral Stent with Suture | 2004 |
What descends from it? (5)
3 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 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, K213444 (Ureteral Stent Company, 2022) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K151051.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Universa® Firm Ureteral Stents and Stent Sets are intended 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/K161236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161236: Universa Firm 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/K161236
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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