510(k) · Cleared
ClearedMiniarc Precise Single-Incision Sling System Model: 720181, 720191
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Jun 7, 2010 as substantially equivalent to K070065 (American Medical Systems, Inc., 2007) and 2 other predicates after a 77-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it.
- Decided
- Jun 7, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K011251 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 4 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 2 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 1 generation backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- This deviceK100807 Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK121641 Miniarc Pro Single-Incision Sling SystemAmerican Medical Systems · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK110420 Ophira Mini Sling SystemPromedon S.A · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −6 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −4 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −3 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −2 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −1 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K100807 | Miniarc Precise Single-Incision Sling System Model: 720181, 720191 | American Medical Systems, Inc. | 2010 | — |
| +1 | K121641 | Miniarc Pro Single-Incision Sling System | American Medical Systems | 2012 | 1 |
| +1 | K110420 | Ophira Mini Sling System | Promedon S.A | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 PAH? 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 PAH device
- #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K070065 | Ams Single Incision Sling System (Sis-0)Summary page 2…me: Surgical Mesh, Polymeric Class: Class I1/21 CFR § 878.3300 Product Code: PAH Predicate Device: Device Name Submission Number Clearance Date MiniArc® Sling System K070065 March 1, 2007 MiniArc® Sling System K071902 August 24, 2007 MiniArc® Sling System K073703 January 20, 2008 Device Description:… | 2007 |
| * | K071902 | Ams Miniarc Sling SystemSummary page 2…1/21 CFR § 878.3300 Product Code: PAH Predicate Device: Device Name Submission Number Clearance Date MiniArc® Sling System K070065 March 1, 2007 MiniArc® Sling System K071902 August 24, 2007 MiniArc® Sling System K073703 January 20, 2008 Device Description: The MiniArc Precise Single-Incision Sling Sy… | 2007 |
| * | K073703 | Ams Miniarc Sling SystemSummary page 2…ate Device: Device Name Submission Number Clearance Date MiniArc® Sling System K070065 March 1, 2007 MiniArc® Sling System K071902 August 24, 2007 MiniArc® Sling System K073703 January 20, 2008 Device Description: The MiniArc Precise Single-Incision Sling System (MiniArc Precise) is a modification of t… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 1 company; a new generation was cleared every 6 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K121641 (American Medical Systems, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070065.
How does its category compare?
All PAH devicesPAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · PAH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PAH
128in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAH
242in 2025
MAUDE reports naming product code PAH, 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 | 61 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 4 | 128 | 0 | 129 |
| 2013 | 0 | — | 0 | 2,386 |
| 2014 | 0 | — | 0 | 338 |
| 2015 | 0 | — | 1 | 275 |
| 2016 | 0 | — | 0 | 697 |
| 2017 | 0 | — | 0 | 127 |
| 2018 | 0 | — | 0 | 174 |
| 2019 | 0 | — | 0 | 298 |
| 2020 | 1 | — | 0 | 171 |
| 2021 | 0 | — | 0 | 318 |
| 2022 | 0 | — | 0 | 159 |
| 2023 | 1 | — | 0 | 154 |
| 2024 | 1 | — | 0 | 287 |
| 2025 | 0 | — | 0 | 242 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MiniArc Precise Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
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/K100807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100807: Miniarc Precise Single-Incision Sling System Model: 720181, 720191.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100807
Report an extraction error
Are you the manufacturer?
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