510(k) · Cleared

Cleared

All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter

K981612510(k) TraditionalCleared Jul 8, 199863-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

Rochester Medical Corp. · EZL Catheter, Retention Type, Balloon

Cleared on Jul 8, 1998 as substantially equivalent to K896053 (Rochester Medical Corp., 1990) after a 63-day review. Its family tree reaches back 1 generation to 1990. 19 later devices descend from it.

Decided: Jul 8, 1998
Review: 63 days
Class: Class II
Product code: EZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K896053 (1990). 19 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
This deviceK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
Descendant · cites it directly · 10 of its ownK082815 Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008
Descendant · cites it directly · 6 of its ownK130908 Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013
Descendant · cites it directly · 2 of its ownK013276 All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002
Descendant · 2 generations on · 1 of its ownK233094 Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024
Descendant · 2 generations on · 1 of its ownK142635 Medline Silicone Foley CatheterMedline Industries, Inc. · 2015 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2002high 3 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 19 · See all

K082815Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008 · cites it directly10descendants
K130908Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd. · 2013 · cites it directly6descendants
K013276All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002 · cites it directly2descendants
K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024 · 2 generations on1descendant
K142635Medline Silicone Foley CatheterMedline Industries, Inc. · 2015 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896053	All Silicone Foley Catheter	Rochester Medical Corp.	1990	—
0 (this device)	K981612	All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter…	Rochester Medical Corp.	1998	—
+1	K082815	Well Lead Silicone and Latex Foley Catheters	Well Lead Medical Instruments	2008	—
+1	K130908	Disposable Silicone Foley Catheter	Guangdong Baihe Medical Technology Co., Ltd.	2013	—
+1	K013276	All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)	Sewoon Medical Co., Ltd.	2002	—
+2	K233094	Wellead® Latex Foley Catheter	Well Lead Medical (Hainan) Co., Ltd.	2024	—
+2	K142635	Medline Silicone Foley Catheter	Medline Industries, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2008	1	0
2009	2	0
2010	1	0
2013	1	0
2015	1	0
2017	3	0
2018	3	0
2019	1	0
2020	1	0
2021	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K981612, 1990–2025Source: 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? (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	Applicant	Decided	Recalls
*	K896053	All Silicone Foley Catheter Summary page 1 …ice The predicate device for purposes of substantial equivalence is the Rochester Medical Corporation All Silicone Foley Carheter which receive marketing approval under K896053, Rusch Foley Catheters, and Bard Urological Inc. Foley Catheters. Intended Use of the Device For urological use only. Device De…	Rochester Medical Corp.	1990	—
*	—	Rusch Foley Catheters Named without a submission number			—
*	—	Bard Urological Inc. Foley Catheters Named without a submission number			—

Also cleared against K896053: 1 other device →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K082815	Well Lead Silicone and Latex Foley Catheters	Well Lead Medical Instruments	2008	10
K130908	Disposable Silicone Foley Catheter	Guangdong Baihe Medical Technology Co., Ltd.	2013	6
K013276	All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)	Sewoon Medical Co., Ltd.	2002	2
K091767	3 Way Silicone Foley Balloon Catheter	Cook Urological, Inc.	2009	1

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?

Its one ancestor has no recall.
Of its descendants, K082815 (Well Lead Medical Instruments, 2008) has gone furthest, with 10 descendants of its own.
1 other device also cites its predicate K896053.

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?

Urethral catheterization for bladder drainage.

Urethral catheterization for bladder drainage and bladder irrigation.

Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.

For urological use only.

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/K981612 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981612

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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