510(k) · Cleared
ClearedI-Stop Trans Obturator Male Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cl Medical · OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Cleared on Nov 7, 2006 as substantially equivalent to K051533 (Cl Medical, 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Nov 7, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- OTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931386 (1993). 41 ancestors in all, the oldest K920213 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · Recalled
- This deviceK063079 I-Stop Trans Obturator Male SlingCl Medical · 2006
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · Recalled
- This deviceK063079 I-Stop Trans Obturator Male SlingCl Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −4 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −3 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −1 | K053371 | Ams Male Transobturator Sling System | American Medical Systems, Inc. | 2006 | 3 |
| 0 (this device) | K063079 | I-Stop Trans Obturator Male Sling | Cl Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 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 OTM? 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 OTM device
- #1 K242960 AdVance™ XP Male Sling System (720163-03)score 11.7 · 12 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 |
|---|---|---|---|
| * | K051533 | I-STOPSummary page 1…300) *Product code: FTL *Regulatory status: Class 11 *Predicate Device: I-STOP K051533 AMS Male Transobturator Sling System K053371 *Device description:… | 2005 |
| * | K053371 | Ams Male Transobturator Sling SystemSummary page 1…Class 11 *Predicate Device: I-STOP K051533 AMS Male Transobturator Sling System K053371 *Device description: I-STOP®g Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one s… | 2006 |
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 13 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 6 of the 41 ancestors have a recall of any class.
How does its category compare?
All OTM devicesOTM Mesh, Surgical, For Stress Urinary Incontinence, Male: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OTM
Too few OTM 510(k)s in any year since 2007 to give a median.
Recalls per year · OTM
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTM
47in 2025
MAUDE reports naming product code OTM, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 1 | 72 |
| 2015 | 0 | — | 0 | 42 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 111 |
| 2019 | 0 | — | 0 | 406 |
| 2020 | 0 | — | 0 | 261 |
| 2021 | 1 | — | 0 | 213 |
| 2022 | 0 | — | 0 | 199 |
| 2023 | 1 | — | 0 | 28 |
| 2024 | 1 | — | 0 | 43 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
I-STOP ® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063079: I-Stop Trans Obturator Male Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063079
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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