510(k) · Cleared

Cleared

Miniguard

K954215510(k) TraditionalCleared May 8, 1996243-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

Advanced Surgical Intervention, Inc. · MNG External Urethral Occluder, Urinary Incontinence-Control, Female

Cleared on May 8, 1996 after a 243-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: May 8, 1996
Review: 243 days
Class: Class I
Product code: MNG
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK954215 MiniguardAdvanced Surgical Intervention, Inc. · 1996
Descendant · cites it directly · 1 of its ownK974600 Uromed PatchUromed Corp. · 1998
Descendant · 2 generations on · 0 of its ownK983164 Restore (Aka RE/Stor)Nebl, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all

K974600Uromed PatchUromed Corp. · 1998 · cites it directly1descendant
K983164Restore (Aka RE/Stor)Nebl, Inc. · 1999 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954215	Miniguard	Advanced Surgical Intervention, Inc.	1996	—
+1	K974600	Uromed Patch	Uromed Corp.	1998	—
+2	K983164	Restore (Aka RE/Stor)	Nebl, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0

FIG. 1 — Lineage of K954215, 1996–1999Source: 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 MNG? 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? (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	Recalls
*	—	Dacomed C3 Male Continence Device Named without a submission number	—
*	—	Diamed External Urinary Appliance Named without a submission number	—
*	—	Xtramedics Fresh 'n Fit Padette Named without a submission number	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K974600	Uromed Patch	Uromed Corp.	1998	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?

Of its descendants, K974600 (Uromed Corp., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MNG devices

MNG External Urethral Occluder, Urinary Incontinence-Control, Female: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNG

FDA has decided no MNG device since 2007.

Median 510(k) review, days · MNG

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

Recalls per year · MNG

No recall names MNG since 2007.

Adverse event reports per year · MNG

No MAUDE report names MNG since 2007.

View these four charts as a table

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

What is it indicated for?

The Miniguard is an external female continence device that is applied to the urinary opening 10 prevent or decrease episodes of stress incontinence. Stress incontinence occurs when intra-abdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who expenence urine leakage under conditions of physical stress.

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/K954215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954215: Miniguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954215

Report an extraction error

Are you the manufacturer?

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