510(k) · Cleared
ClearedAltis Single Incision Cling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Nov 5, 2012 as substantially equivalent to K050148 (Mentor Corporation, 2005) and 2 other predicates after a 160-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 5, 2012
- Review
- 160 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K011251 (2001). 13 ancestors in all, the oldest K974098 (1998). 2 later devices descend from it, 1 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 deviceK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
- Descendant · cites it directly · 1 of its ownK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
- Descendant · 2 generations on · 0 of its ownK242473 Altis Single Incision Sling System (519650); Aris Transobturator…Coloplast Corp. · 2024
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) | K121562 | Altis Single Incision Cling System | Coloplast A/S | 2012 | — |
| +1 | K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023 | — |
| +2 | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System… | Coloplast Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitSummary page 1…tem) is substantially equivalent in performance, indications, design and materials to Coloplast's Aris System (previously Mentor's), cleared under premarket notification K050 148 on March 9, 2005, American Medical System's MiniArc System, cleared under premarket notification K073703 on January 30, 2008 and… | 2005 |
| * | K073703 | Ams Miniarc Sling SystemSummary page 1…tem (previously Mentor's), cleared under premarket notification K050 148 on March 9, 2005, American Medical System's MiniArc System, cleared under premarket notification K073703 on January 30, 2008 and C.R. Bard Ajust Adjustable Single Incision Sling, cleared under premarket notification K092607 on Novembe… | 2008 |
| * | K092607 | Ajust Adjustable Single Incision SlingSummary page 1…niArc System, cleared under premarket notification K073703 on January 30, 2008 and C.R. Bard Ajust Adjustable Single Incision Sling, cleared under premarket notification K092607 on November 20, 2009. Device Description: The Altis System is a single-incision mini-sling.. The sling material is manufactured… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221874 | Altis Single Incision Sling System | 2023 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K221874 (Coloplast A/S, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K050148.
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 Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility, and/or intrinsic sphincter deficiency (ISD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121562: Altis Single Incision Cling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121562
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