510(k) · Cleared
ClearedMale Remeex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialities Remeex International, S.L. · OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Cleared on Nov 2, 2006 as substantially equivalent to K033310 (Specialities Remeex International, S.L., 2004) after an 84-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Nov 2, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- OTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033310 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK033310 Remeex System for Urinary IncontinenceSpecialities Remeex International, S.L. · 2004
- This deviceK062341 Male Remeex SystemSpecialities Remeex International, S.L. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033310 | Remeex System for Urinary Incontinence | Specialities Remeex International, S.L. | 2004 | — |
| 0 (this device) | K062341 | Male Remeex System | Specialities Remeex International, S.L. | 2006 | — |
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 OTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OTM device
- #1 K242960 AdVance™ XP Male Sling System (720163-03)score 11.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K033310 | Remeex System for Urinary IncontinenceSummary page 1…as a pubourethral sling for the treatment of urinary incontinence: Device | 510(k) . Date Cleared | Indications . - | Document o : SR - - | Number B R S B REMEEX SYSTEM K033310 1/15/2004 Urinary Incontinence Technologically, both the proposed and predicate devices are the same (i.e. both are meshes that… | 2004 |
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.
- 2 other devices also cite its predicate K033310.
How does its category compare?
All OTM devicesOTM Mesh, Surgical, For Stress Urinary Incontinence, Male: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OTM
Too few OTM 510(k)s in any year since 2007 to give a median.
Recalls per year · OTM
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTM
47in 2025
MAUDE reports naming product code OTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 1 | 72 |
| 2015 | 0 | — | 0 | 42 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 111 |
| 2019 | 0 | — | 0 | 406 |
| 2020 | 0 | — | 0 | 261 |
| 2021 | 1 | — | 0 | 213 |
| 2022 | 0 | — | 0 | 199 |
| 2023 | 1 | — | 0 | 28 |
| 2024 | 1 | — | 0 | 43 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Male Remeex System is intended to be used as a pubourethral sling for the
treatment of male stress urinary 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/K062341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062341: Male Remeex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062341
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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