510(k) · Cleared

Cleared

Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence

K970308510(k) TraditionalCleared Apr 2, 199765-day reviewClass I21 CFR 876.5160

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

Mentor Urology, Inc. · FHA Clamp, Penile

Cleared on Apr 2, 1997 after a 65-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided: Apr 2, 1997
Review: 65 days
Class: Class I
Product code: FHA
Recalls: None
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K970308Source: FDA 510(k) database · 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 FHA? 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

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K884426	Bard Cunningham Incontinence Clamp Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …ification; Class I per 21CFR876.5250, Urological Clamp for Males, Code 78FHA. 3. Identification of Substantially Equivalent Device Bard Cunningham Incontinence Clamp, #K884426 4. Device Description The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for…

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.

How does its category compare?

All FHA devices

FHA Clamp, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHA

FDA has decided no FHA device since 2007.

Median 510(k) review, days · FHA

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

Recalls per year · FHA

No recall names FHA since 2007.

Adverse event reports per year · FHA

1in 2023

2007high 5 (2014) · low 0 (2007)2025

MAUDE reports naming product code FHA, 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	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	1
2013	—	1
2014	—	5
2015	—	0
2016	—	0
2017	—	5
2018	—	5
2019	—	3
2020	—	1
2021	—	0
2022	—	2
2023	—	1
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.

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/K970308 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970308: Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970308

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026