510(k) · Decided
DecidedCook Ureteral Balloon Dilation Catheter Set
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 Apr 6, 2004 as substantially equivalent to K813278 (Vance Products, Inc., 1981) and 2 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Apr 6, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K813278 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK813278 Vpi Ureteral Dilatation Ballon CatheterVance Products, Inc. · 1981
- This deviceK040127 Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813278 | Vpi Ureteral Dilatation Ballon Catheter | Vance Products, Inc. | 1981 | — |
| 0 (this device) | K040127 | Cook Ureteral Balloon Dilation Catheter Set | Cook Urological, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 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? (5)
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 |
|---|---|---|---|
| * | K813278 | Vpi Ureteral Dilatation Ballon CatheterSummary page 1…Catheter Set is substantial equivalent to predicate devices in terms of indications for use and design. Predicate devices include the Balloon Ureteral Dilator Set, D.C. #K8 13278 manufactured by Cook Urological, Accent DGTM Balloon Ureteral Dilator Set, D.C. #K905375 manufactured by Cook Urololgical, Ascend… | 1981 |
| * | K905375 | Accent DG Balloon Ureteral Dilator SetSummary page 1…e and design. Predicate devices include the Balloon Ureteral Dilator Set, D.C. #K8 13278 manufactured by Cook Urological, Accent DGTM Balloon Ureteral Dilator Set, D.C. #K905375 manufactured by Cook Urololgical, AscendTm Balloon Dilation Catheter, D.C. #K970041, the Balloon Dilation Catheters manufactured… | 1991 |
| * | K970041 | Ascend Balloon Dailation CatheterSummary page 1…3278 manufactured by Cook Urological, Accent DGTM Balloon Ureteral Dilator Set, D.C. #K905375 manufactured by Cook Urololgical, AscendTm Balloon Dilation Catheter, D.C. #K970041, the Balloon Dilation Catheters manufactured by Bard and the High Pressure Ureteral Dilatation Balloon Catheter manufactured by M… | 1997 |
| * | — | Balloon Dilation Catheters Named without a submission number | |
| * | — | High Pressure Ureteral Dilatation Balloon Catheter Named without a submission number |
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?
- None of the 3 ancestors has a 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 Cook Ureteral Balloon Dilation Catheter Set is used for Dilation prior to stone manipulation or ureteroscopy, and Dilating the intramural ureter. This device is sterile And intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040127: Cook Ureteral Balloon Dilation Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040127
Report an extraction error
Are you the manufacturer?
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