510(k) · Cleared
ClearedFossa Ureteral Open Lumen Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fossa Medical, Inc. · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Nov 26, 2003 as substantially equivalent to K031292 (Fossa Medical, Inc., 2003) and 1 other predicate after a 36-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Nov 26, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021602 (2002). 3 ancestors in all, the oldest K021140 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK021602 Fossa Ureteral Stone SweeperFossa Industries, Inc. · 2002
- 1 generation backK031292 Modification to Fossa Ureteral Stone SweeperFossa Medical, Inc. · 2003
- This deviceK033368 Fossa Ureteral Open Lumen StentFossa Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK072293 Fossa Ureteral Open StentsFossa Medical, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072293Fossa Ureteral Open StentsFossa Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021602 | Fossa Ureteral Stone Sweeper | Fossa Industries, Inc. | 2002 | — |
| −1 | K031292 | Modification to Fossa Ureteral Stone Sweeper | Fossa Medical, Inc. | 2003 | — |
| 0 (this device) | K033368 | Fossa Ureteral Open Lumen Stent | Fossa Medical, Inc. | 2003 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 EYB? 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 EYB device
- #1 K192183 RocaTub Ureteral Catheterscore -0.2 · 3 generations · no Class I recall
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072293 | Fossa Ureteral Open Stents | 2008 | 0 |
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 1 year and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072293 (Fossa Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EYB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EYB
248in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EYB
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EYB
11in 2025
MAUDE reports naming product code EYB, 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 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 1 | 15 |
| 2009 | 1 | — | 0 | 42 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 3 | 248 | 0 | 22 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Fossa Ureteral Open Lumen 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/K033368 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033368: Fossa Ureteral Open Lumen Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033368
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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