510(k) · Cleared
Recalled · Class II · 2014Cure 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 Aug 1, 2011 as substantially equivalent to K072539 (Cure Medical, LLC, 2007) and 1 other predicate after a 147-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 1, 2011
- Review
- 147 days
- Class
- Class II
- Product code
- EZD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896729 (1990). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
- 2 generations backK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- 1 generation backK072539 Cure CatheterCure Medical, LLC · 2007 · Recalled
- This deviceK110653 Cure CatheterCure Medical, LLC · 2011
- 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −3 | K896729 | Nelaton-, Female - or Tiemann Catheter | Unoplast A/S | 1990 | 14 |
| −2 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| −1 | K072539 | Cure Catheter | Cure Medical, LLC | 2007 | 1 |
| 0 (this device) | K110653 | Cure Catheter | Cure Medical, LLC | 2011 | — |
| +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 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K072539 | Cure CatheterSummary page 1…3)]: 510(k) Trade or Proprietary or Model Name Manufacturer Number ______________ __ 1 K072539 1 Cure Catheter 1 Cure Medical 2 K080881 2 Cure Catheter Closed System… | 2007 |
| * | K080881 | Cure Catheter Closed SystemSummary page 1…acturer Number ______________ __ 1 K072539 1 Cure Catheter 1 Cure Medical 2 K080881 2 Cure Catheter Closed System 2 Cure Medical Description of the device: The Cure Pediatric Catheter devic… | 2008 |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Nov 11, 2014 | Class II | Z-0496-2015 | Labeling mix-ups | Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K132500 (Cure Medical, LLC, 2013) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K072539.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric 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/K110653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110653: 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/K110653
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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