510(k) · Cleared
ClearedRestorelle Y Contour Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Feb 12, 2014 as substantially equivalent to K123914 (Coloplast A/S, 2013) after a 27-day review. Its family tree reaches back 13 generations to 1993. 1 later device descends from it.
- Decided
- Feb 12, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K931386 (1993). 38 ancestors in all, the oldest K905655 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations between
- 3 generations backK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- 2 generations backK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
- 1 generation backK123914 Restorelle Y ContourColoplast A/S · 2013
- This deviceK140116 Restorelle Y Contour MeshColoplast A/S · 2014
- Descendant · cites it directly · 0 of its ownK173501 Meridian Vaginal Positioning System (VPS)Coloplast · 2018
Show all 13 generations
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 12 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 11 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 10 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 9 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 8 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 7 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 6 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 5 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 4 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 3 generations backK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
- 2 generations backK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
- 1 generation backK123914 Restorelle Y ContourColoplast A/S · 2013
- This deviceK140116 Restorelle Y Contour MeshColoplast A/S · 2014
Most influential descendants
Showing 1 of 1 · See all- K173501Meridian Vaginal Positioning System (VPS)Coloplast · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −12 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −11 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −10 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −9 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −8 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −7 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −6 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −5 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −4 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| −3 | K092207 | Restorelle Polypropylene Mesh | Mpathy Medical Devices, Inc. | 2009 | — |
| −2 | K112322 | Restorelle Polypropylene Y Mesh | Coloplast A/S | 2012 | — |
| −1 | K123914 | Restorelle Y Contour | Coloplast A/S | 2013 | — |
| 0 (this device) | K140116 | Restorelle Y Contour Mesh | Coloplast A/S | 2014 | — |
| +1 | K173501 | Meridian Vaginal Positioning System (VPS) | Coloplast | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K123914 | Restorelle Y ContourSummary page 1…and uterine prolapse, transabdominally placed) Predicate Devices: Restorelle Y Contour (K1 239 14) Description of Device: Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypr… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173501 | Meridian Vaginal Positioning System (VPS) | 2018 | 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?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K173501 (Coloplast, 2018) has gone furthest, with 0 descendants of its own.
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. 2014, 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?
Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140116: Restorelle Y Contour Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140116
Report an extraction error
Are you the manufacturer?
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