510(k) · Cleared
ClearedMentor Obtape Trans-Obturator Surgical Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Nov 9, 2004 as substantially equivalent to K031767 (Mentor Corp., 2003) after a 25-day review. Its family tree reaches back 3 generations to 2001. 8 later devices descend from it.
- Decided
- Nov 9, 2004
- Review
- 25 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011251 (2001). 4 ancestors in all, the oldest K974098 (1998). 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 2 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 1 generation backK031767 Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
- This deviceK042851 Mentor Obtape Trans-Obturator Surgical KitMentor Corp. · 2004
- Descendant · cites it directly · 7 of its ownK050148 Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation · 2005
- Descendant · 2 generations on · 2 of its ownK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
- Descendant · 2 generations on · 2 of its ownK053296 Mentor Aris Suprapubic Surgical KitMentor Corporation · 2005
- Descendant · 3 generations on · 1 of its ownK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
- Descendant · 3 generations on · 1 of its ownK111233 Supris Retropubic Sling SystemColoplast A/S · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050148Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation · 2005 · cites it directly7descendants
- K121562Altis Single Incision Cling SystemColoplast A/S · 2012 · 2 generations on2descendants
- K053296Mentor Aris Suprapubic Surgical KitMentor Corporation · 2005 · 2 generations on2descendants
- K221874Altis Single Incision Sling SystemColoplast A/S · 2023 · 3 generations on1descendant
- K111233Supris Retropubic Sling SystemColoplast A/S · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −2 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −1 | K031767 | Mentor Obtape Trans-Obturator Tape | Mentor Corp. | 2003 | — |
| 0 (this device) | K042851 | Mentor Obtape Trans-Obturator Surgical Kit | Mentor Corp. | 2004 | — |
| +1 | K050148 | Mentor Aris Trans-Obturator Tape and Surgical Kit | Mentor Corporation | 2005 | — |
| +2 | K121562 | Altis Single Incision Cling System | Coloplast A/S | 2012 | — |
| +2 | K053296 | Mentor Aris Suprapubic Surgical Kit | Mentor Corporation | 2005 | — |
| +3 | K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023 | — |
| +3 | K111233 | Supris Retropubic Sling System | Coloplast A/S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K031767 | Mentor Obtape Trans-Obturator TapeSummary page 1…l Kit is substantially equivalent in material, function, performance and design to the Mentor ObTape Trans-obturator Tape and Introducers which were cleared under 510(k) K031767. - 000012 Xo&’z,{?’/z/b Indications for Use Mentor ObTape Trans-obturator Surgical Kit is indicated for the su… | 2003 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050148 | Mentor Aris Trans-Obturator Tape and Surgical Kit | 2005 | 7 |
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 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050148 (Mentor Corporation, 2005) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K031767.
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 Mentor ObTape Trans-obturator Surgical Kit consists of an implantable, suburethral support tape and introducers. It is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resuiting from urethral hypermobility and/or 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/K042851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042851: Mentor Obtape Trans-Obturator Surgical Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042851
Report an extraction error
Are you the manufacturer?
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