510(k) · Cleared
ClearedAms Large Pore Polyprophlene Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Oct 16, 2012 as substantially equivalent to K040521 (American Medical Systems, Inc., 2004) after a 119-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Oct 16, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931386 (1993). 14 ancestors in all, the oldest K922916 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 6 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 5 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 4 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 3 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 2 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 1 generation backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- This deviceK121805 Ams Large Pore Polyprophlene MeshAmerican Medical Systems · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −7 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −6 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −5 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −4 | 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 | — |
| −2 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −1 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K121805 | Ams Large Pore Polyprophlene Mesh | American Medical Systems | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 OTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040521 | Modification to Ams Large Pore Polypropylene MeshSummary page 1…Class: Class 111/21 CFR § 878.3300 Product Code: OTO Predicate Device: IntePro® AMS Large Pore Polypropylene Mesh (K040521) Device Description: The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The me… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040521.
How does its category compare?
All OTO devicesOTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OTO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OTO
95in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTO
No recall names OTO since 2007.
Adverse event reports per year · OTO
79in 2025
MAUDE reports naming product code OTO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 7 | 101 | 0 | 160 |
| 2013 | 4 | 95 | 0 | 2,272 |
| 2014 | 1 | — | 0 | 267 |
| 2015 | 2 | — | 0 | 448 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 0 | — | 0 | 145 |
| 2019 | 0 | — | 0 | 347 |
| 2020 | 0 | — | 0 | 153 |
| 2021 | 0 | — | 0 | 292 |
| 2022 | 0 | — | 0 | 112 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 113 |
| 2025 | 0 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121805: Ams Large Pore Polyprophlene Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121805
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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