510(k) · Cleared
ClearedFemassist Flexible
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 Feb 12, 1998 as substantially equivalent to K963858 (Insight Medical Corp., 1997) after a 62-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 12, 1998
- Review
- 62 days
- Class
- Class I
- Product code
- MNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963858 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963858 Femassist Urinary DeviceInsight Medical Corp. · 1997
- This deviceK974645 Femassist FlexibleInsight Medical Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963858 | Femassist Urinary Device | Insight Medical Corp. | 1997 | — |
| 0 (this device) | K974645 | Femassist Flexible | Insight Medical Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | K963858 | Femassist Urinary DeviceSummary page 1…CFR 876.5160. The FemAssist™ product code is 78MNG. Predicate Device: FemAssist™ Manufactured and Distributed by: INSIGHT Medical Corp. 580 Main Street Bolton, MA 01740 K963858 Product Description: The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with… | 1997 |
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 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 INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
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/K974645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974645: Femassist Flexible.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974645
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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