510(k) · Cleared
ClearedGMD Universal Urinary Incontinence Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Generic Medical Device, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Jun 30, 2011 as substantially equivalent to K083471 (Generic Medical Device, Inc., 2009) and 1 other predicate after a 59-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Jun 30, 2011
- Review
- 59 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K011251 (2001). 19 ancestors in all, the oldest K974098 (1998). No later device cites it as a predicate yet.
- Root · 11 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations between
- 3 generations backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- 2 generations backK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
- 1 generation backK101440 GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010
- This deviceK111219 GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
Show all 11 generations
- Root · 11 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 10 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 9 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 8 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 7 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 6 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 5 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 4 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 3 generations backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- 2 generations backK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
- 1 generation backK101440 GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010
- This deviceK111219 GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −10 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −9 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −8 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −7 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −6 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −5 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −4 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| −3 | K081275 | Boston Scientific Surgical Mesh | Boston Scientific Corp | 2008 | — |
| −2 | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | Generic Medical Device, Inc. | 2009 | 2 |
| −1 | K101440 | GMD Universal Urinary Incontinence Sling, Model 1012 | Generic Medical Devices, Inc. | 2010 | — |
| 0 (this device) | K111219 | GMD Universal Urinary Incontinence Sling | Generic Medical Device, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020Summary page 1…versal Urinary Incontinence Sling™-1011 Common Name: Mesh, Surgical, Polymeric Regulatory Class: Class Il Product Codes: OTN Predicate Device(s): GMD Universal Sling (K083471) GMD Universal Sling™-1012 (K101440) Device Description: The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, singl… | 2009 |
| * | K101440 | GMD Universal Urinary Incontinence Sling, Model 1012Summary page 1…11 Common Name: Mesh, Surgical, Polymeric Regulatory Class: Class Il Product Codes: OTN Predicate Device(s): GMD Universal Sling (K083471) GMD Universal Sling™-1012 (K101440) Device Description: The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, single use device for the treatment of fem… | 2010 |
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 10 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 2 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083471.
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. 2011, this device’s year, is highlighted.
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 GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach.
The use of the device in males and children under 18 years of age is not supported by clinical studies.
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/K111219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111219: GMD Universal Urinary Incontinence Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111219
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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