510(k) · Cleared
ClearedFemale Length All Silicone Urological Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochester Medical Corp. · EZL Catheter, Retention Type, Balloon
Cleared on Mar 6, 1995 after a 334-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 6, 1995
- Review
- 334 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK941692 Female Length All Silicone Urological CatheterRochester Medical Corp. · 1995
- Descendant · cites it directly · 5 of its ownK961697 Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996
- Descendant · 2 generations on · 3 of its ownK023090 Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 2 of its ownK033830 Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V…Opticon Medical, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK041983 Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · Recalled
- Descendant · 4 generations on · 0 of its ownK062240 CareventChief Medical, LLC · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K961697Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996 · cites it directly5descendants
- K023090Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · 2 generations on3descendants
- K033830Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…Opticon Medical, Inc. · 2004 · 3 generations on2descendants
- K041983Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · 3 generations on1descendant
- K062240CareventChief Medical, LLC · 2006 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941692 | Female Length All Silicone Urological Catheter | Rochester Medical Corp. | 1995 | — |
| +1 | K961697 | Opticon Female Urinary Incontinence Catheter for Continuous Drainage | Medical Device Intl., Inc. | 1996 | — |
| +2 | K023090 | Option-VF Urinary Catheter, FV14218 | Opticon Medical, Inc. | 2003 | 1 |
| +3 | K033830 | Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous… | Opticon Medical, Inc. | 2004 | — |
| +3 | K041983 | Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016 | Opticon Medical | 2004 | 1 |
| +4 | K062240 | Carevent | Chief Medical, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961697 | Opticon Female Urinary Incontinence Catheter for Continuous Drainage | 1996 | 5 |
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, K961697 (Medical Device Intl., Inc., 1996) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K941692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941692: Female Length All Silicone Urological Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941692
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026