510(k) · Cleared
ClearedMentor Obtape Trans-Obturator Tape
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 Jul 17, 2003 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 1 other predicate after a 38-day review. Its family tree reaches back 2 generations to 2001. 15 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 38 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011251 (2001). 3 ancestors in all, the oldest K974098 (1998). 15 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 1 generation backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- This deviceK031767 Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
- Descendant · cites it directly · 8 of its ownK042851 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 · cites it directly · 5 of its ownK061445 Surgimesh WNAspide Medical · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK072974 Surgimesh XBAspide Medical · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K042851Mentor Obtape Trans-Obturator Surgical KitMentor Corp. · 2004 · cites it directly8descendants
- K050148Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation · 2005 · cites it directly7descendants
- K061445Surgimesh WNAspide Medical · 2007 · cites it directly5descendants
- K072974Surgimesh XBAspide Medical · 2008 · 2 generations on3descendants
- K121562Altis Single Incision Cling SystemColoplast A/S · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −1 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K031767 | Mentor Obtape Trans-Obturator Tape | Mentor Corp. | 2003 | — |
| +1 | K042851 | Mentor Obtape Trans-Obturator Surgical Kit | Mentor Corp. | 2004 | — |
| +1 | K050148 | Mentor Aris Trans-Obturator Tape and Surgical Kit | Mentor Corporation | 2005 | — |
| +1 | K061445 | Surgimesh WN | Aspide Medical | 2007 | 2 |
| +2 | K072974 | Surgimesh XB | Aspide Medical | 2008 | 2 |
| +2 | K121562 | Altis Single Incision Cling System | Coloplast A/S | 2012 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 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? (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 |
|---|---|---|---|
| * | K974098 | Pubouurethral SlingSummary page 1…dles necessary for the implantation are also available with the device. Similar to Johnson and Johnson's Tension Free Vaginal Tape (TVT) System cleared under 510(k) No: K974098 and American Medical Systems' Sparc Sling System cleared under 510(k) K013355, ObTape will be manufactured from polypropylene mat… | 1998 |
| * | K013355 | Sparc Sling SystemSummary page 1…ar to Johnson and Johnson's Tension Free Vaginal Tape (TVT) System cleared under 510(k) No: K974098 and American Medical Systems' Sparc Sling System cleared under 510(k) K013355, ObTape will be manufactured from polypropylene material. Substantial Equivalence Claim The Mentor ObTape Trans-obturator Tape… | 2001 |
What descends from it? (15)
See all 153 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042851 (Mentor Corp., 2004) has gone furthest, with 8 descendants of its own.
- 11 other devices also cite its predicate K974098.
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?
Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral 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/K031767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031767: Mentor Obtape Trans-Obturator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031767
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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