510(k) · Decided
DecidedCure Catheter Closed System; Cure Dextra Closed System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Inc. · EZD Catheter, Straight
Cleared on Nov 8, 2023 as substantially equivalent to K080881 (Cure Medical, LLC, 2008) after a 266-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Nov 8, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010420 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010420 Rusch MMG/O'neil CatheterRusch, Inc. · 2001 · Recalled
- 1 generation backK080881 Cure Catheter Closed SystemCure Medical, LLC · 2008
- This deviceK230400 Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250891 Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2)…Convatec Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…Convatec Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010420 | Rusch MMG/O'neil Catheter | Rusch, Inc. | 2001 | 3 |
| −1 | K080881 | Cure Catheter Closed System | Cure Medical, LLC | 2008 | — |
| 0 (this device) | K230400 | Cure Catheter Closed System; Cure Dextra Closed System | Convatec, Inc. | 2023 | — |
| +1 | K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure… | Convatec Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K080881 | Cure Catheter Closed SystemSummary page 4…6.5130 Regulation Name: Urological Catheter and Accessories Product Code: EZD Primary Predicate: Cure Catheter® Closed System, K080881 Device Description: The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to b… | 2008 |
| † | K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter… | 2025 | 0 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K250891 (Convatec Limited, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K080881.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.
The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.
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/K230400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230400: Cure Catheter Closed System; Cure Dextra Closed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230400
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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