510(k) · Cleared
Recalled · Class II · 2012Cure Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cure Medical, LLC · EZD Catheter, Straight
Cleared on Sep 13, 2007 as substantially equivalent to K033023 (Rusch Intl., 2003) after a 3-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 13, 2007
- Review
- 3 days
- Class
- Class II
- Product code
- EZD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896729 (1990). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
- 1 generation backK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- This deviceK072539 Cure CatheterCure Medical, LLC · 2007
- Descendant · cites it directly · 4 of its ownK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
- Descendant · cites it directly · 3 of its ownK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK260737 Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female…Convatec · 2026
- Descendant · 2 generations on · 0 of its ownK181445 AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK151745 FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K110653Cure CatheterCure Medical, LLC · 2011 · cites it directly4descendants
- K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC · 2013 · cites it directly3descendants
- K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…Convatec · 2026 · 2 generations on0descendants
- K181445AMSure Hydrophilic Intermittent CatheterAmsino International, Inc. · 2018 · 2 generations on0descendants
- K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896729 | Nelaton-, Female - or Tiemann Catheter | Unoplast A/S | 1990 | 14 |
| −1 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| 0 (this device) | K072539 | Cure Catheter | Cure Medical, LLC | 2007 | — |
| +1 | K110653 | Cure Catheter | Cure Medical, LLC | 2011 | 1 |
| +1 | K132500 | Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter… | Cure Medical, LLC | 2013 | — |
| +2 | K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 -… | Convatec | 2026 | — |
| +2 | K181445 | AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. | 2018 | — |
| +1 | K151745 | FULL CARE Disposable PVC Nelaton Catheter | Shaoxing Fuqing Health Products Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033023 | Intermittent Urethral CathetersSummary page 1…KOD CFR Reference: 876.5130 Predicate Device: Rusch Easy Cath Intermittent Catheters Predicate 510(k) #: K033023 (Rusch) Device Description: The Cure CatheterTm device is an intermittent urinary cat… | 2003 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2012 | Class II | Z-0004-2013 | Labeling mix-ups | The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K110653 (Cure Medical, LLC, 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K033023.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Catheter is an intermittent urinary catheter 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 packaged sterile for single-use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072539: Cure Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072539
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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