510(k) · Cleared
ClearedModification to Fossa Ureteral Stone Sweeper
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 May 22, 2003 as substantially equivalent to K021602 (Fossa Industries, Inc., 2002) after a 29-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- May 22, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- FAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021602 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK021602 Fossa Ureteral Stone SweeperFossa Industries, Inc. · 2002
- This deviceK031292 Modification to Fossa Ureteral Stone SweeperFossa Medical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK033368 Fossa Ureteral Open Lumen StentFossa Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK072293 Fossa Ureteral Open StentsFossa Medical, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021602 | Fossa Ureteral Stone Sweeper | Fossa Industries, Inc. | 2002 | — |
| 0 (this device) | K031292 | Modification to Fossa Ureteral Stone Sweeper | Fossa Medical, Inc. | 2003 | — |
| +1 | K033368 | Fossa Ureteral Open Lumen Stent | Fossa Medical, Inc. | 2003 | — |
| +2 | K072293 | Fossa Ureteral Open Stents | Fossa Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K021602 | Fossa Ureteral Stone Sweeper | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033368 | Fossa Ureteral Open Lumen Stent | 2003 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K033368 (Fossa Medical, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder, and/or for the manipulation, capture and removal of urinary calculi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031292: Modification to Fossa Ureteral Stone Sweeper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031292
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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