510(k) · Cleared
ClearedTriangle Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Mar 27, 1998 as substantially equivalent to K972651 (Influence, Inc., 1997) after a 46-day review. Its family tree reaches back 3 generations to 1993. 114 later devices descend from it.
- Decided
- Mar 27, 1998
- Review
- 46 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931386 (1993). 4 ancestors in all. 114 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 2 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 1 generation backK972651 IN-SlingInfluence, Inc. · 1997
- This deviceK980482 Triangle SlingInfluence, Inc. · 1998
- Descendant · cites it directly · 113 of its ownK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- Descendant · 2 generations on · 80 of its ownK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- Descendant · 3 generations on · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- Descendant · 4 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- Descendant · 4 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000 · cites it directly113descendants
- K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001 · 2 generations on80descendants
- K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · 3 generations on79descendants
- K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 4 generations on74descendants
- K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −2 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −1 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| 0 (this device) | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| +1 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| +2 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| +3 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| +4 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| +4 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 13 | 0 |
| 2009 | 9 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 14 | 0 |
| 2013 | 9 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K972651 | IN-SlingSummary page 1…105 Telephone: 415-546-7700/Fax: 415-546-7744 Trade Name: TriAngle Sling Cl:;ssification Name: Mesh, Surgical, Polymeric (7 OTN ) Predicate Device: Influence In-Sling (K972651) Indication for Use: The TriAngle Sling is intended to be used as a sling in transvaginal sling procedures for the treatment of… | 1997 |
What descends from it? (114)
See all 1141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | 2000 | 113 |
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 5 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K002721 (American Medical Systems, Inc., 2000) has gone furthest, with 113 descendants 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 TriAngle Sling is indicated to be used as a sling in transvaginal sling procedures for the treatment of urinary stress 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/K980482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980482: Triangle Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980482
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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