510(k) · Cleared
ClearedSof-Flex Ureteral Stent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FAD Stent, Ureteral
Cleared on Sep 13, 2018 as substantially equivalent to K151051 (Cook Incorporated, 2016) and 1 other predicate after a 248-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Sep 13, 2018
- Review
- 248 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K903345 (1991). 10 ancestors in all, the oldest K905289 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK903345 Bard (R) Lubricious - Coated Ureteral Stent SutureC.R. Bard, Inc. · 1991
- 5 generations backK983498 Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture…C.R. Bard, Inc. · 1998 · Recalled
- 4 generations backK022447 Bard ER Ureteral Stent with SutureC.R. Bard, Inc. · 2003
- 3 generations backK043193 Bard Inlayoptima Ureteral Stent with SutureC.R. Bard, Inc. · 2004 · Recalled
- 2 generations backK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- 1 generation backK162104 C-Flex Ureteral Stent SetCook Incorporated · 2017
- This deviceK180053 Sof-Flex Ureteral Stent SetCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard, Inc. | 1991 | — |
| −5 | K983498 | Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter… | C.R. Bard, Inc. | 1998 | 2 |
| −4 | K022447 | Bard ER Ureteral Stent with Suture | C.R. Bard, Inc. | 2003 | — |
| −3 | K043193 | Bard Inlayoptima Ureteral Stent with Suture | C.R. Bard, Inc. | 2004 | 6 |
| −2 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| −1 | K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017 | — |
| 0 (this device) | K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 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…ification Panel: Class II, Gastroenterology/Urology Predicate Devices: • Primary predicate device: Universa™ Soft Ureteral Stents and Stent Sets (K151051) • Secondary predicate device: C-Flex® Ureteral Stent Set (K162104) Reference Device: • Kwart Retro-Inje… | 2016 |
| * | K162104 | C-Flex Ureteral Stent SetSummary page 4…ry predicate device: Universa™ Soft Ureteral Stents and Stent Sets (K151051) • Secondary predicate device: C-Flex® Ureteral Stent Set (K162104) Reference Device: • Kwart Retro-Inject Ureteral Stent (K162109)… | 2017 |
| † | K162109 | Kwart Retro-Inject Ureteral Stent | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 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. 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 Sof-Flex Ureteral Stent Set is intended for temporary internal drainage from the ureteropelvic junction to the bladder. Sof-Flex ureteral stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques.
The 3 French stents are indicated for pediatric patients.
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/K180053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180053: Sof-Flex Ureteral Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180053
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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