510(k) · Cleared
ClearedExair Anterior and Posterior Prolapse Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Sep 8, 2011 as substantially equivalent to K083499 (Coloplast A/S, 2009) after a 21-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Sep 8, 2011
- Review
- 21 days
- Class
- Class III
- Product code
- OTP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931386 (1993). 27 ancestors in all, the oldest K922916 (1992). No later device cites it as a predicate yet.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 1 generation backK083499 Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S · 2009
- This deviceK112386 Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp. · 2011
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 1 generation backK083499 Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S · 2009
- This deviceK112386 Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −5 | 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 | — |
| −3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −2 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| −1 | K083499 | Exair Anterior and Posterior Prolapse Repair Systems | Coloplast A/S | 2009 | — |
| 0 (this device) | K112386 | Exair Anterior and Posterior Prolapse Repair System | Coloplast Corp. | 2011 | — |
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 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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 OTP? 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 |
|---|---|---|---|
| * | K083499 | Exair Anterior and Posterior Prolapse Repair SystemsSummary page 1…Classification Name: Surgical mesh, polymeric Classification: 21 CFR §878.3300 Product Code: OoTP Predicate Devices: Exair Anterior and Posterior Prolapse Repair System (K083499) Description of Device: The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape w… | 2009 |
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 18 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 3 of the 27 ancestors have a recall of any class.
How does its category compare?
All OTP devicesOTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OTP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OTP
71in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTP
No recall names OTP since 2007.
Adverse event reports per year · OTP
26in 2025
MAUDE reports naming product code OTP, 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 | 4 | 90 | 0 | 1 |
| 2008 | 8 | 103 | 0 | 0 |
| 2009 | 6 | 21 | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 5 | 71 | 0 | 32 |
| 2012 | 2 | — | 0 | 494 |
| 2013 | 0 | — | 0 | 7,150 |
| 2014 | 0 | — | 0 | 778 |
| 2015 | 0 | — | 0 | 684 |
| 2016 | 0 | — | 0 | 415 |
| 2017 | 0 | — | 0 | 273 |
| 2018 | 0 | — | 0 | 392 |
| 2019 | 0 | — | 0 | 368 |
| 2020 | 0 | — | 0 | 175 |
| 2021 | 0 | — | 0 | 647 |
| 2022 | 0 | — | 0 | 114 |
| 2023 | 0 | — | 0 | 59 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
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/K112386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112386: Exair Anterior and Posterior Prolapse Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112386
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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