510(k) · Cleared
ClearedArcSP Suprapubic Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urocure, LLC · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Sep 21, 2022 as substantially equivalent to K183134 (Urocure, LLC, 2019) after a 51-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Sep 21, 2022
- Review
- 51 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K011251 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations between
- 3 generations backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- 2 generations backK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- 1 generation backK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
- This deviceK222293 ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
Show all 10 generations
- Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 9 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 8 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 7 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 6 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 5 generations backK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- 4 generations backK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- 3 generations backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- 2 generations backK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- 1 generation backK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
- This deviceK222293 ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −9 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −8 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −7 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −6 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −5 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
| −4 | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | American Medical Systems, Inc. | 2004 | — |
| −3 | K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | American Medical Systems, Inc. | 2008 | — |
| −2 | K132655 | Retroarc Retropubic Sling System | American Medical Systems, Inc. | 2013 | — |
| −1 | K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019 | — |
| 0 (this device) | K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K183134 | ArcTV Transvaginal Sling SystemSummary page 5…he predicate (ArcTV), with the delivery tool being the only difference from the predicate, ArcTV. 7.6 PREDICATE DEVICE The predicate is ArcTV Transvaginal Sling System (K183134). 7.7 DEVICE DESCRIPTION The ArcSP Suprapubic Sling System consists of the following: • 1 ArcSP Sling with bio-resorbable Sut… | 2019 |
| † | K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | 2008 |
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 21 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K183134.
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. 2022, 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 ArcSP Suprapubic Sling System is indicated to be placed at the mid-urethra 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/K222293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222293: ArcSP Suprapubic 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/K222293
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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