510(k) · Cleared
ClearedRemeex System for Urinary Incontinence
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialities Remeex International, S.L. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Jan 15, 2004 after a 93-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 93 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK033310 Remeex System for Urinary IncontinenceSpecialities Remeex International, S.L. · 2004
- Descendant · cites it directly · 1 of its ownK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK092203 Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK071754 Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK062341 Male Remeex SystemSpecialities Remeex International, S.L. · 2006
Most influential descendants
Showing 4 of 4 · See all- K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009 · cites it directly1descendant
- K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009 · 2 generations on0descendants
- K071754Neo-Vagina Surgery Set and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2009 · cites it directly0descendants
- K062341Male Remeex SystemSpecialities Remeex International, S.L. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033310 | Remeex System for Urinary Incontinence | Specialities Remeex International, S.L. | 2004 | — |
| +1 | K091180 | Minitape Urethral Sling | Mpathy Medical Devices, Ltd. | 2009 | — |
| +2 | K092203 | Omnisure Urethral Sling, Model OTK52 | Mpathy Medical Devices, Ltd. | 2009 | — |
| +1 | K071754 | Neo-Vagina Surgery Set and Accessories | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
| +1 | K062341 | Male Remeex System | Specialities Remeex International, S.L. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 3 | 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 OTN? 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 OTN device
- #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 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 |
|---|---|---|---|
| * | — | Ethicon/Gynecare Pubourethral Sling Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K091180 (Mpathy Medical Devices, Ltd., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OTN devicesOTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OTN
89in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTN
458in 2025
MAUDE reports naming product code OTN, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 100 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 5 | 25 | 0 | 1 |
| 2011 | 4 | 56 | 0 | 25 |
| 2012 | 1 | — | 0 | 874 |
| 2013 | 5 | 86 | 0 | 19,084 |
| 2014 | 1 | — | 1 | 2,063 |
| 2015 | 0 | — | 0 | 3,904 |
| 2016 | 0 | — | 0 | 1,902 |
| 2017 | 1 | — | 0 | 676 |
| 2018 | 0 | — | 0 | 737 |
| 2019 | 1 | — | 0 | 2,457 |
| 2020 | 1 | — | 0 | 1,003 |
| 2021 | 3 | 89 | 0 | 2,606 |
| 2022 | 2 | — | 0 | 809 |
| 2023 | 1 | — | 0 | 1,076 |
| 2024 | 0 | — | 0 | 822 |
| 2025 | 0 | — | 0 | 458 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.
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/K033310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033310: Remeex System for Urinary Incontinence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033310
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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