510(k) · Cleared
ClearedAscend Balloon Dailation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · EZN Dilator, Catheter, Ureteral
Cleared on Mar 19, 1997 after a 72-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 19, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK970041 Ascend Balloon Dailation CatheterCook Urological, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK072749 Sialo Balloon Dilatation CatheterSialo Technology, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK172588 Balloon Catheter and Balloon Ureteral Dilator SetCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK140593 Advance Salivary Balloon Catheter with Wire GuideCook, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK040127 Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K072749Sialo Balloon Dilatation CatheterSialo Technology, Ltd. · 2008 · cites it directly1descendant
- K172588Balloon Catheter and Balloon Ureteral Dilator SetCook Incorporated · 2018 · cites it directly0descendants
- K140593Advance Salivary Balloon Catheter with Wire GuideCook, Inc. · 2014 · 2 generations on0descendants
- K040127Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970041 | Ascend Balloon Dailation Catheter | Cook Urological, Inc. | 1997 | — |
| +1 | K072749 | Sialo Balloon Dilatation Catheter | Sialo Technology, Ltd. | 2008 | — |
| +1 | K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | 2018 | — |
| +2 | K140593 | Advance Salivary Balloon Catheter with Wire Guide | Cook, Inc. | 2014 | — |
| +1 | K040127 | Cook Ureteral Balloon Dilation Catheter Set | Cook Urological, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | — | Balloon Dilation Catheters manufactured by Bard Named without a submission number | |
| * | — | High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072749 (Sialo Technology, Ltd., 2008) has gone furthest, with 1 descendant of its own.
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 Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter.
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/K970041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970041: Ascend Balloon Dailation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970041
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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