510(k) · Cleared
ClearedMentor Suspend Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · FTL Mesh, Surgical, Polymeric
Cleared on Apr 30, 1998 after an 80-day review. The FDA summary names its predicate without a number. 297 later devices descend from it.
- Decided
- Apr 30, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
297 later devices descend from it, 7 citing it directly.
- This deviceK980483 Mentor Suspend SlingMentor Corp. · 1998
- Descendant · cites it directly · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
- Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- Descendant · cites it directly · 113 of its ownK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- Descendant · 3 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- Descendant · 3 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
Showing 5 of 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · See all- K992159Surgisis SlingCook Biotech, Inc. · 1999 · cites it directly204descendants
- K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
- K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000 · cites it directly113descendants
- K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 3 generations on102descendants
- K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 3 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980483 | Mentor Suspend Sling | Mentor Corp. | 1998 | — |
| +1 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| +2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| +1 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| +3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| +3 | K031969 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 15 | 0 |
| 2007 | 10 | 0 |
| 2008 | 22 | 0 |
| 2009 | 22 | 0 |
| 2010 | 13 | 0 |
| 2011 | 14 | 0 |
| 2012 | 20 | 0 |
| 2013 | 15 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 14 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | — | GoreTex™ Tissue Reinforcement Patch Named without a submission number | |
| * | — | ProteGen™ Sling Named without a submission number |
What descends from it? (297)
See all 2977 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992159 | Surgisis Sling | 1999 | 204 |
| K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | 2000 | 113 |
| K020110 | Modification to Trelex Mesh Surgical Mesh | 2002 | 38 |
| K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304 | 2004 | 29 |
| K090271 | Hydrocoat Mesh | 2010 | 6 |
| K041176 | Uretex to Trans-Obturator Urethral Support System | 2004 | 4 |
| K012949 | Uretex Sup Pubourethral Sling | 2001 | 0 |
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, K992159 (Cook Biotech, Inc., 1999) has gone furthest, with 204 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists for the urological anatomy inclusive of the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, reconstruction of the pelvic floor, and sacro-culposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility 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/K980483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980483: Mentor Suspend Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980483
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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