510(k) · Cleared
Recalled · 2007Pathway Balloon Expandable Ureteral Access Sheath, Model Beus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onset Medical Corporation · EZN Dilator, Catheter, Ureteral
Cleared on May 2, 2006 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 9 times.
- Decided
- May 2, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- EZN
- Recalls
- 9
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZN? 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 EZN device
- #1 K250910 Optilume® High Pressure Urological Balloon…score 10.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2007 | Not classified | Z-0905-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0909-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0912-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0913-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0906-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0907-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0908-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0911-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Nov 30, 2007 | Not classified | Z-0910-2008 | Device Design | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZN
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZN
9in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZN
79in 2025
MAUDE reports naming product code EZN, 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 | — | 9 | 23 |
| 2008 | 0 | — | 0 | 53 |
| 2009 | 0 | — | 0 | 124 |
| 2010 | 0 | — | 0 | 52 |
| 2011 | 0 | — | 0 | 54 |
| 2012 | 0 | — | 0 | 38 |
| 2013 | 2 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 65 |
| 2018 | 4 | 175 | 0 | 58 |
| 2019 | 1 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 40 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 83 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Onset Medical Pathway TM Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061009: Pathway Balloon Expandable Ureteral Access Sheath, Model Beus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026