510(k) · Cleared

Cleared

Opticon Female Urinary Incontinence Catheter for Continuous Drainage

K961697510(k) TraditionalCleared Aug 30, 1996120-day reviewClass II21 CFR 876.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Device Intl., Inc. · EZL Catheter, Retention Type, Balloon

Cleared on Aug 30, 1996 as substantially equivalent to K760093 (C.R. Bard, Inc., 1976) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1976. 5 later devices descend from it.

Decided: Aug 30, 1996
Review: 120 days
Class: Class II
Product code: EZL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K760093 (1976). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK760093 Catheter, Silicone Foley (Bardex)C.R. Bard, Inc. · 1976 · Recalled
This deviceK961697 Opticon Female Urinary Incontinence Catheter for Continuous DrainageMedical Device Intl., Inc. · 1996
Descendant · cites it directly · 3 of its ownK023090 Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · Recalled
Descendant · 2 generations on · 2 of its ownK033830 Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V…Opticon Medical, Inc. · 2004
Descendant · 2 generations on · 1 of its ownK041983 Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · Recalled
Descendant · 3 generations on · 0 of its ownK062240 CareventChief Medical, LLC · 2006
Descendant · cites it directly · 0 of its ownK970716 Opticon Direct Male Urinary Catheter for Continuous DrainageOpticon Medical, Inc. · 1997

Most influential descendants

Showing 5 of 5 · See all

K023090Option-VF Urinary Catheter, FV14218Opticon Medical, Inc. · 2003 · cites it directly3descendants
K033830Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…Opticon Medical, Inc. · 2004 · 2 generations on2descendants
K041983Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical · 2004 · 2 generations on1descendant
K062240CareventChief Medical, LLC · 2006 · 3 generations on0descendants
K970716Opticon Direct Male Urinary Catheter for Continuous DrainageOpticon Medical, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760093	Catheter, Silicone Foley (Bardex)	C.R. Bard, Inc.	1976	1
0 (this device)	K961697	Opticon Female Urinary Incontinence Catheter for Continuous Drainage	Medical Device Intl., Inc.	1996	—
+1	K023090	Option-VF Urinary Catheter, FV14218	Opticon Medical, Inc.	2003	1
+2	K033830	Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous…	Opticon Medical, Inc.	2004	—
+2	K041983	Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016	Opticon Medical	2004	1
+3	K062240	Carevent	Chief Medical, LLC	2006	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2003	1	0
2004	2	0
2006	1	0

FIG. 1 — Lineage of K961697, 1976–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K760093	Catheter, Silicone Foley (Bardex) Summary page 1 …Catheter SUBSTANTIALLY EQUIVALENT TO: The OPTICON™ Female Urinary Catheter for Continuous Drainage is substantially equivalent to the Bardex Silicone Foley Catheter (K760093) and the Rochester Medical Female Uretheral Catheter (K941692). DESCRIPTION of the DEVICE: The OPTICON™ Female Urinary Catheter…	C.R. Bard, Inc.	1976	1
*	K941692	Female Length All Silicone Urological Catheter Summary page 1 …rinary Catheter for Continuous Drainage is substantially equivalent to the Bardex Silicone Foley Catheter (K760093) and the Rochester Medical Female Uretheral Catheter (K941692). DESCRIPTION of the DEVICE: The OPTICON™ Female Urinary Catheter for Continuous Draisage is a sterile, single use/dispossble, f…	Rochester Medical Corp.	1995	—

Also cleared against K760093: 3 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023090	Option-VF Urinary Catheter, FV14218	Opticon Medical, Inc.	2003	3
K970716	Opticon Direct Male Urinary Catheter for Continuous Drainage	Opticon Medical, Inc.	1997	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K023090 (Opticon Medical, Inc., 2003) has gone furthest, with 3 descendants of its own.
3 other devices also cite its predicate K760093.

How does its category compare?

All EZL devices

EZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZL

1in 2025

2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZL

123in 2024

2007high 282 (2023) · low 114 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EZL

2in 2024

2007high 2 (2023) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · EZL

1,381in 2025

2007high 1,381 (2025) · low 6 (2008)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™ Female Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be conpected to standard drainage tubes, drainage rubc 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/K961697 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961697: Opticon Female Urinary Incontinence Catheter for Continuous Drainage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961697

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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