510(k) · Cleared
ClearedSparc Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Oct 26, 2001 as substantially equivalent to K011251 (American Medical Systems, Inc., 2001) after a 16-day review. Its family tree reaches back 1 generation to 2001. 120 later devices descend from it.
- Decided
- Oct 26, 2001
- Review
- 16 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011251 (2001). 120 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- This deviceK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- Descendant · cites it directly · 110 of its ownK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- Descendant · cites it directly · 109 of its ownK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- Descendant · cites it directly · 102 of its ownK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- Descendant · cites it directly · 81 of its ownK030123 Bioarc SP Sling KitAmerican Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly110descendants
- K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly109descendants
- K023516Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly102descendants
- K030123Bioarc SP Sling KitAmerican Medical Systems, Inc. · 2003 · cites it directly81descendants
- K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| +1 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| +1 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| +1 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| +1 | K030123 | Bioarc SP Sling Kit | American Medical Systems, Inc. | 2003 | — |
| +2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 16 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 15 | 0 |
| 2013 | 7 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K011251 | Sparc Sling SystemSummary page 1…tion Name: Predicate Device: Device Description <D — Surgical Mesh, Sling, Urethral Sling SPARC™ Sling System Jeet DS Surgical Mesh, polymeric SPARC™ Sling System - K011251 The SPARC™ Sling System is a sterile, single use procedure kit consisting of: ¢ Two stainless steel, curved, 22-cm long, needle… | 2001 |
What descends from it? (120)
See all 12010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020663 | Modification to Sparc Sling System | 2002 | 110 |
| K021263 | Modification to Sparc Sling System | 2002 | 109 |
| K023516 | Monarc Sling System | 2002 | 102 |
| K030123 | Bioarc SP Sling Kit | 2003 | 81 |
| K040537 | Ams Apogee Vault Suspension System | 2004 | 70 |
| K031767 | Mentor Obtape Trans-Obturator Tape | 2003 | 15 |
| K053296 | Mentor Aris Suprapubic Surgical Kit | 2005 | 2 |
| K091180 | Minitape Urethral Sling | 2009 | 1 |
| K051533 | I-STOP | 2005 | 1 |
| K092203 | Omnisure Urethral Sling, Model OTK52 | 2009 | 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?
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.
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 SPARC™ Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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/K013355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013355: Sparc Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013355
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026