510(k) · Cleared
ClearedSelf Retaining Male External Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · EXJ Device, Incontinence, Urosheath Type, Sterile
Cleared on Sep 16, 1996 as substantially equivalent to K940269 (Hollister, Inc., 1994) after a 53-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 16, 1996
- Review
- 53 days
- Class
- Class I
- Product code
- EXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940269 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940269 Hollister Non-Rolled Self-Adhesive Urinary External CatheterHollister, Inc. · 1994
- This deviceK962900 Self Retaining Male External Urinary CatheterHollister, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940269 | Hollister Non-Rolled Self-Adhesive Urinary External Catheter | Hollister, Inc. | 1994 | — |
| 0 (this device) | K962900 | Self Retaining Male External Urinary Catheter | Hollister, Inc. | 1996 | — |
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 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
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 | Decided |
|---|---|---|---|
| * | K940269 | Hollister Non-Rolled Self-Adhesive Urinary External CatheterSummary page 1…3, 1996 2. Name of Device: Hollister Self Retaining Male External Urinary Catheter 3. Name of Predicate Device(s) Hollister Non-Rolled Male External Urinary Catheter K#940269 Mentor Active Cath Self Adhesive Male External Urinary Catheter 4. Description of Device The Hollister Self Retaining Male Exter… | 1994 |
| * | — | Mentor Active Cath Self Adhesive Male External Urinary Catheter Named without a submission number |
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 EXJ devicesEXJ 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
MAUDE reports naming product code EXJ, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.
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/K962900 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962900: Self Retaining Male External Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962900
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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