510(k) · Cleared
ClearedFemassist Urinary Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insight Medical Corp. · MNG External Urethral Occluder, Urinary Incontinence-Control, Female
Cleared on Oct 21, 1997 after a 391-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Oct 21, 1997
- Review
- 391 days
- Class
- Class I
- Product code
- MNG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963858 Femassist Urinary DeviceInsight Medical Corp. · 1997
- Descendant · cites it directly · 0 of its ownK974645 Femassist FlexibleInsight Medical Corp. · 1998
Most influential descendants
Showing 1 of 1 · See all- K974645Femassist FlexibleInsight Medical Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963858 | Femassist Urinary Device | Insight Medical Corp. | 1997 | — |
| +1 | K974645 | Femassist Flexible | Insight Medical Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | Miniguard (Impress) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974645 | Femassist Flexible | 1998 | 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, K974645 (Insight Medical Corp., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MNG devicesMNG 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FemAssietTM is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (sSuI).
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/K963858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963858: Femassist Urinary Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963858
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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