510(k) · Cleared
Recalled · Class II · 2013Restorelle L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Nov 19, 2012 as substantially equivalent to K120327 (Caldera Medical, Inc., 2012) after a 101-day review. Its family tree reaches back 12 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 19, 2012
- Review
- 101 days
- Class
- Class II
- Product code
- OTO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 12 generations to K931386 (1993). 28 ancestors in all, the oldest K922916 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations between
- 3 generations backK083722 AscendCaldera Medical, Inc. · 2009
- 2 generations backK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- 1 generation backK120327 VertessaCaldera Medical, Inc. · 2012
- This deviceK122440 Restorelle LColoplast Corp. · 2012
- Descendant · cites it directly · 0 of its ownK132061 Restorelle M, Restorelle XLColoplast Corp. · 2013
Show all 12 generations
- Root · 12 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 11 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 10 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 9 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 8 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 7 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 6 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 5 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 4 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 3 generations backK083722 AscendCaldera Medical, Inc. · 2009
- 2 generations backK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- 1 generation backK120327 VertessaCaldera Medical, Inc. · 2012
- This deviceK122440 Restorelle LColoplast Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K132061Restorelle M, Restorelle XLColoplast Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −11 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −10 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −9 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −8 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −7 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −6 | 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 | — |
| −4 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −3 | K083722 | Ascend | Caldera Medical, Inc. | 2009 | — |
| −2 | K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | Caldera Medical, Inc. | 2010 | — |
| −1 | K120327 | Vertessa | Caldera Medical, Inc. | 2012 | — |
| 0 (this device) | K122440 | Restorelle L | Coloplast Corp. | 2012 | — |
| +1 | K132061 | Restorelle M, Restorelle XL | Coloplast Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K101322 | FDA’s K101322 is Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K120327 | VertessaSummary page 1…Prolapse, Transabdominally Placed. Predicate Devices: Restorelle® Y (KI 12322), VertessaTm Polypropylene Mesh (Ki120327) Description of Device: Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constmucted of knitted non-absorba… | 2012 |
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 |
|---|---|---|---|
| K132061 | Restorelle M, Restorelle XL | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2013 | Class II | Z-1341-2013 | Labeling mix-ups | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K132061 (Coloplast Corp., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120327.
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?
Restorelle L is indicated for use as a 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/K122440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122440: Restorelle L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122440
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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