510(k) · Cleared
Recalled · Class II · 2015Miniarc Pro Single-Incision Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Sep 7, 2012 as substantially equivalent to K100807 (American Medical Systems, Inc., 2010) after a 95-day review. Its family tree reaches back 9 generations to 2001. It has been recalled once.
- Decided
- Sep 7, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- PAH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K011251 (2001). No later device cites it as a predicate yet.
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 1 generation backK100807 Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
- This deviceK121641 Miniarc Pro Single-Incision Sling SystemAmerican Medical Systems · 2012
Show all 9 generations
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 8 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 6 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 1 generation backK100807 Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
- This deviceK121641 Miniarc Pro Single-Incision Sling SystemAmerican Medical Systems · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −8 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −6 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −4 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −3 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −2 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| −1 | K100807 | Miniarc Precise Single-Incision Sling System Model: 720181, 720191 | American Medical Systems, Inc. | 2010 | — |
| 0 (this device) | K121641 | Miniarc Pro Single-Incision Sling System | American Medical Systems | 2012 | — |
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? (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 |
|---|---|---|---|
| * | K100807 | Miniarc Precise Single-Incision Sling System Model: 720181, 720191Summary page 1…ss: Class 11 / 21 CFR § 878.3300 Product Code: PAH Predicate Device: MiniArc® Precise Single-Incision Sling System (K 100807) Device Description: The MiniAre® Pro Sling System is designed to treat female stress urinary incontinence resulting from ureth… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2015 | Class II | Z-0279-2016 | Labeling mix-ups | The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K100807.
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. 2012, 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®8 Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUL) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121641: Miniarc Pro Single-Incision Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121641
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