510(k) · Cleared
ClearedSympacath Hydrogel Coated Foley
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · EZL Catheter, Retention Type, Balloon
Cleared on Feb 4, 1997 after an 82-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Feb 4, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK964575 Sympacath Hydrogel Coated FoleyRusch Intl. · 1997
- Descendant · cites it directly · 9 of its ownK033023 Intermittent Urethral CathetersRusch Intl. · 2003
- Descendant · 2 generations on · 5 of its ownK072539 Cure CatheterCure Medical, LLC · 2007 · Recalled
- Descendant · 3 generations on · 4 of its ownK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
- Descendant · 3 generations on · 3 of its ownK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
- Descendant · 2 generations on · 2 of its ownK111405 Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip /…Hangzhou Bever Medical Devices Co., Ltd. · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K033023Intermittent Urethral CathetersRusch Intl. · 2003 · cites it directly9descendants
- K072539Cure CatheterCure Medical, LLC · 2007 · 2 generations on5descendants
- K110653Cure CatheterCure Medical, LLC · 2011 · 3 generations on4descendants
- K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC · 2013 · 3 generations on3descendants
- K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Hangzhou Bever Medical Devices Co., Ltd. · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964575 | Sympacath Hydrogel Coated Foley | Rusch Intl. | 1997 | — |
| +1 | K033023 | Intermittent Urethral Catheters | Rusch Intl. | 2003 | — |
| +2 | K072539 | Cure Catheter | Cure Medical, LLC | 2007 | 1 |
| +3 | K110653 | Cure Catheter | Cure Medical, LLC | 2011 | 1 |
| +3 | K132500 | Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter… | Cure Medical, LLC | 2013 | — |
| +2 | K111405 | Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip… | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 EZL? 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 EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Bard Biocath Named without a submission number | |
| * | — | Lubricath Named without a submission number | |
| * | — | Curity Kendall Ultramer coated catheters Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033023 | Intermittent Urethral Catheters | 2003 | 9 |
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, K033023 (Rusch Intl., 2003) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, 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 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.
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/K964575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964575: Sympacath Hydrogel Coated Foley.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964575
Report an extraction error
Are you the manufacturer?
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