510(k) · Cleared
ClearedCook 810 Set, Desilets-Hoffman Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · EZN Dilator, Catheter, Ureteral
Cleared on May 2, 2018 as substantially equivalent to K851144 (Van-Tec, Inc., 1985) after a 119-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- May 2, 2018
- Review
- 119 days
- Class
- Class II
- Product code
- EZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851144 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK851144 Ureteral Dilation SetVan-Tec, Inc. · 1985
- This deviceK180028 Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851144 | Ureteral Dilation Set | Van-Tec, Inc. | 1985 | — |
| 0 (this device) | K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | 2018 | — |
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? (1)
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 |
|---|---|---|---|
| * | K851144 | Ureteral Dilation SetSummary page 4…EZN, Gastroenterology/Urology Predicate Device: Boston Scientific’s 8/10 Dilator/Sheath Set, cleared for commercial distribution under 510(k) number K851144 Device Description: The Ureteral Introducer Sets is a bundle of two Ureteral Introducer Sets, composed of the Cook® 810 Set and… | 1985 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K851144.
How does its category compare?
All EZN devicesEZN Dilator, Catheter, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 810 Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.
The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180028: Cook 810 Set, Desilets-Hoffman Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180028
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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