510(k) · Cleared

Cleared

Hollister Non-Rolled Self-Adhesive Urinary External Catheter

K940269510(k) TraditionalCleared Jun 2, 1994132-day reviewClass I21 CFR 876.5250

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

Hollister, Inc. · EXJ Device, Incontinence, Urosheath Type, Sterile

Cleared on Jun 2, 1994 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jun 2, 1994
Review: 132 days
Class: Class I
Product code: EXJ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK940269 Hollister Non-Rolled Self-Adhesive Urinary External CatheterHollister, Inc. · 1994
Descendant · cites it directly · 0 of its ownK962900 Self Retaining Male External Urinary CatheterHollister, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all

K962900Self Retaining Male External Urinary CatheterHollister, Inc. · 1996 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940269	Hollister Non-Rolled Self-Adhesive Urinary External Catheter	Hollister, Inc.	1994	—
+1	K962900	Self Retaining Male External Urinary Catheter	Hollister, Inc.	1996	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K940269, 1994–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K962900	Self Retaining Male External Urinary Catheter	Hollister, Inc.	1996	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?

Of its descendants, K962900 (Hollister, Inc., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EXJ devices

EXJ Device, Incontinence, Urosheath Type, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EXJ

FDA has decided no EXJ device since 2007.

Median 510(k) review, days · EXJ

Too few EXJ 510(k)s in any year since 2007 to give a median.

Recalls per year · EXJ

No recall names EXJ since 2007.

Adverse event reports per year · EXJ

1in 2022

2007high 6 (2015) · low 0 (2008)2025

MAUDE reports naming product code EXJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	2
2008	—	0
2009	—	1
2010	—	1
2011	—	5
2012	—	5
2013	—	3
2014	—	1
2015	—	6
2016	—	6
2017	—	1
2018	—	0
2019	—	0
2020	—	1
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K940269 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940269: Hollister Non-Rolled Self-Adhesive Urinary External Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940269

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026