510(k) · Cleared

Cleared

American Catheter, Model W3

K030538510(k) TraditionalCleared Mar 10, 200318-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

Cleared on Mar 10, 2003 as substantially equivalent to K863082 (Cook Urological, Inc., 1986) after an 18-day review. Its family tree reaches back 1 generation to 1986.

Decided: Mar 10, 2003
Review: 18 days
Class: Class II
Product code: EZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K863082 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK863082 Cook-Vpi Intermittent CatheterCook Urological, Inc. · 1986
This deviceK030538 American Catheter, Model W3Catheter, LLC · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863082	Cook-Vpi Intermittent Catheter	Cook Urological, Inc.	1986	—
0 (this device)	K030538	American Catheter, Model W3	Catheter, LLC	2003	—

FIG. 1 — Lineage of K030538, 1986–2003Source: 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 EZD? 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 EZD device

#1 K241210 Luja Coudescore 16.2 · 7 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? (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	Applicant	Decided	Recalls
*	K863082	Cook-Vpi Intermittent Catheter Summary page 1 …C. Devanney Product Code: KOD Predicate device: Device Classification Name: Catheter, Urological Regulation Number: 8 7 6 . 5 1 3 0 5 1 0 (K) Number: K863082 Device Name: COOK-VPI INTERMITTENT CATHETER Applicant: Cook Urological, Inc.…	Cook Urological, Inc.	1986	—

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?

Its one ancestor has no recall.

How does its category compare?

All EZD devices

EZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZD

11so far in 2026, the most since 2007

2007high 11 (2026) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZD

130in 2025

2007high 288 (2022) · low 83 (2016)2026

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

Recalls per year · EZD

1in 2014

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EZD

288in 2025

2007high 994 (2021) · low 0 (2007)2025

MAUDE reports naming product code EZD, 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	4	121	0	0
2008	1	—	0	0
2009	2	—	0	4
2010	2	—	0	6
2011	4	116	1	4
2012	2	—	1	2
2013	4	110	0	18
2014	5	91	1	17
2015	1	—	0	21
2016	3	83	0	21
2017	2	—	0	120
2018	3	122	0	390
2019	0	—	0	466
2020	1	—	0	563
2021	0	—	0	994
2022	10	288	0	487
2023	6	214	0	553
2024	5	147	0	116
2025	6	130	0	288
2026	11	146	0	—

What is it indicated for?

Used for female intermittent self-catheterization of the bladder. Curved design permits ease of placement. The grip area makes the catheter easier for patients to manipulate.

Non-sterile

Reusable.

Intended for single patient use

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030538: American Catheter, Model W3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030538

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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