510(k) · Cleared
ClearedRestore (Aka RE/Stor)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nebl, Inc. · MNG External Urethral Occluder, Urinary Incontinence-Control, Female
Cleared on Mar 5, 1999 as substantially equivalent to K974600 (Uromed Corp., 1998) and 1 other predicate after a 176-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 5, 1999
- Review
- 176 days
- Class
- Class I
- Product code
- MNG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954215 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954215 | Miniguard | Advanced Surgical Intervention, Inc. | 1996 | — |
| −1 | K974600 | Uromed Patch | Uromed Corp. | 1998 | — |
| 0 (this device) | K983164 | Restore (Aka RE/Stor) | Nebl, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K974600 | Uromed PatchSummary page 1…e Incontinence Device Classification Name: Device, urethral occlusion for incontinence Classification Code: 78MNG 3. Predicate Devices: Impress Soft Patch (Uromed Inc) K974600 Restore (NEBL Inc.) K971359 4. Device Description Restore Female Continence device is a simple, noninvasive suction cup which… | 1998 |
| * | K971359 | Restore (a.K.a. Capsure)Summary page 1…ification Name: Device, urethral occlusion for incontinence Classification Code: 78MNG 3. Predicate Devices: Impress Soft Patch (Uromed Inc) K974600 Restore (NEBL Inc.) K971359 4. Device Description Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus… | 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a 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 Restore device is indicated for the prevention or-decrease of eplsodes of urine leakage in women with stress incontinence.
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/K983164 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983164: Restore (Aka RE/Stor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983164
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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