510(k) · Cleared
ClearedOpticon Direct Male Urinary Catheter for Continuous Drainage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opticon Medical, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on May 16, 1997 as substantially equivalent to K961697 (Medical Device Intl., Inc., 1996) after a 78-day review. Its family tree reaches back 2 generations to 1976.
- Decided
- May 16, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K760093 (1976). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK760093 Catheter, Silicone Foley (Bardex)C.R. Bard, Inc. · 1976 · Recalled
- 1 generation backK961697 Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996
- This deviceK970716 Opticon Direct Male Urinary Catheter for Continuous DrainageOpticon Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760093 | Catheter, Silicone Foley (Bardex) | C.R. Bard, Inc. | 1976 | 1 |
| −1 | K961697 | Opticon Female Urinary Incontinence Catheter for Continuous Drainage | Medical Device Intl., Inc. | 1996 | — |
| 0 (this device) | K970716 | Opticon Direct Male Urinary Catheter for Continuous Drainage | Opticon Medical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (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 |
|---|---|---|---|
| * | K961697 | Opticon Female Urinary Incontinence Catheter for Continuous DrainageSummary page 1…O: The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is substantially equivalent to the OPTICON™ Direct Femnale Urinary Catheter for Continuous Drainage (K961697). DESCRIPTION of the DEVICE: The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is a sterile, single use/disposa… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K961697.
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?
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.
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/K970716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970716: Opticon Direct Male Urinary Catheter for Continuous Drainage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970716
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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