510(k) · Cleared
ClearedFossa Ureteral Open Stents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fossa Medical, Inc. · FAD Stent, Ureteral
Cleared on Aug 6, 2008 as substantially equivalent to K033368 (Fossa Medical, Inc., 2003) and 1 other predicate after a 356-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Aug 6, 2008
- Review
- 356 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K021602 (2002). 4 ancestors in all, the oldest K021140 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021602 Fossa Ureteral Stone SweeperFossa Industries, Inc. · 2002
- 2 generations backK031292 Modification to Fossa Ureteral Stone SweeperFossa Medical, Inc. · 2003
- 1 generation backK033368 Fossa Ureteral Open Lumen StentFossa Medical, Inc. · 2003
- This deviceK072293 Fossa Ureteral Open StentsFossa Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021602 | Fossa Ureteral Stone Sweeper | Fossa Industries, Inc. | 2002 | — |
| −2 | K031292 | Modification to Fossa Ureteral Stone Sweeper | Fossa Medical, Inc. | 2003 | — |
| −1 | K033368 | Fossa Ureteral Open Lumen Stent | Fossa Medical, Inc. | 2003 | — |
| 0 (this device) | K072293 | Fossa Ureteral Open Stents | Fossa Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K033368 | Fossa Ureteral Open Lumen StentSummary page 1…Performance Standards (78FAD), and is classified under 21 CFR 876.4620. Predicate Devices: Fossa Open Lumen Stent (K033368) Fossa Double Pigtail Expanding Ureteral Stent (K021140) Product Description: The Fossa Ureteral O… | 2003 |
| * | K021140 | Fossa Expanding Double Pigtail Ureteral StentSummary page 1…21 CFR 876.4620. Predicate Devices: Fossa Open Lumen Stent (K033368) Fossa Double Pigtail Expanding Ureteral Stent (K021140) Product Description: The Fossa Ureteral Open-8 Stent set consists of a flexible, pigtail-tipped stent with a radiopaque push ca… | 2002 |
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 6 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to
promote drainage of urine from the kidney to the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072293: Fossa Ureteral Open Stents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072293
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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