510(k) · Cleared
ClearedIN-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 Sep 19, 1997 as substantially equivalent to K963226 (Boston Scientific Corp, 1996) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 1993. 115 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 67 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931386 (1993). 3 ancestors in all. 115 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 1 generation backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- This deviceK972651 IN-SlingInfluence, Inc. · 1997
- Descendant · cites it directly · 114 of its ownK980482 Triangle SlingInfluence, Inc. · 1998
- Descendant · 2 generations on · 113 of its ownK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- Descendant · 3 generations on · 80 of its ownK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- Descendant · 4 generations on · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- Descendant · 5 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K980482Triangle SlingInfluence, Inc. · 1998 · cites it directly114descendants
- K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000 · 2 generations on113descendants
- K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001 · 3 generations on80descendants
- K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · 4 generations on79descendants
- K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 5 generations on74descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −1 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| 0 (this device) | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| +1 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| +2 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| +3 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| +4 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| +5 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K963226 | Surgical FabricsSummary page 2…reviewed by the Plastic and Reconstructive Surgery Devices Branch. 8-2 WDC - 70356/300 - 0480290 01 Predicate Devices: « Surgical Fabrics’ ProteGen™ (K963226) o Vascutek’s Gelsea™ (K963611) Performance Standards: No performance standards applicable to surgical mesh have been establish… | 1996 |
| * | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek…Summary page 2…constructive Surgery Devices Branch. 8-2 WDC - 70356/300 - 0480290 01 Predicate Devices: « Surgical Fabrics’ ProteGen™ (K963226) o Vascutek’s Gelsea™ (K963611) Performance Standards: No performance standards applicable to surgical mesh have been established by the FDA. “Indication for… | 1996 |
What descends from it? (115)
See all 1151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980482 | Triangle Sling | 1998 | 114 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K980482 (Influence, Inc., 1998) has gone furthest, with 114 descendants of its own.
- 1 other device also cites its predicate K963226.
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 IN-SLING™ is intended 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/K972651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972651: IN-Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972651
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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