510(k) · Cleared
ClearedUreteral Dilation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Van-Tec, Inc. · EZN Dilator, Catheter, Ureteral
Cleared on Apr 9, 1985 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 9, 1985
- Review
- 19 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK851144 Ureteral Dilation SetVan-Tec, Inc. · 1985
- Descendant · cites it directly · 1 of its ownK172527 Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal…Cook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK213334 Monarch Platform, UrologyAuris Health, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK180756 Safety Wire Guide IntroducerCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK180028 Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated · 2018
Most influential descendants
Showing 4 of 4 · See all- K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz…Cook Incorporated · 2017 · cites it directly1descendant
- K213334Monarch Platform, UrologyAuris Health, Inc. · 2022 · 2 generations on0descendants
- K180756Safety Wire Guide IntroducerCook Incorporated · 2018 · cites it directly0descendants
- K180028Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851144 | Ureteral Dilation Set | Van-Tec, Inc. | 1985 | — |
| +1 | K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set… | Cook Incorporated | 2017 | — |
| +2 | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | 1 |
| +1 | K180756 | Safety Wire Guide Introducer | Cook Incorporated | 2018 | — |
| +1 | K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
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, K172527 (Cook Incorporated, 2017) 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 | — |
https://510kreport.com/device/K851144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K851144: Ureteral Dilation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851144
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026