510(k) · Cleared
ClearedAltis Single Incision Sling 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 Feb 15, 2023 as substantially equivalent to K121562 (Coloplast A/S, 2012) after a 232-day review. Its family tree reaches back 9 generations to 2001. 1 later device descends from it.
- Decided
- Feb 15, 2023
- Review
- 232 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K011251 (2001). 14 ancestors in all, the oldest K974098 (1998). 1 later device descends from it, 1 citing it directly.
- 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 backK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
- This deviceK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
- Descendant · cites it directly · 0 of its ownK242473 Altis Single Incision Sling System (519650); Aris Transobturator…Coloplast Corp. · 2024
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 backK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
- This deviceK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
Most influential descendants
Showing 1 of 1 · See all- K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…Coloplast Corp. · 2024 · cites it directly0descendants
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 | K121562 | Altis Single Incision Cling System | Coloplast A/S | 2012 | — |
| 0 (this device) | K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K121562 | Altis Single Incision Cling SystemSummary page 4…ulatory Class: II Review Panel: Gastroenterology/Urology III. PREDICATE DEVICE 510(k) Number: K121562 Trade Name: Altis® Single Incision Sling System The predicate has not been subjected to a design-rela… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)… | 2024 | 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K242473 (Coloplast Corp., 2024) has gone furthest, with 0 descendants of its own.
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. 2023, 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/K221874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221874: Altis Single Incision 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/K221874
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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