510(k) Report

510(k) · Cleared

Cleared

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)

K242473510(k) TraditionalCleared Oct 18, 202459-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coloplast Corp. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Cleared on Oct 18, 2024 as substantially equivalent to K221874 (Coloplast A/S, 2023) and 2 other predicates after a 59-day review. Its family tree reaches back 10 generations to 2001.

Decided
Oct 18, 2024
Review
59 days
Class
Class II
Product code
PAH
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K011251 (2001). 17 ancestors in all, the oldest K974098 (1998). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor2003: 1 other ancestor2009: 1 other ancestor1998: 1 other ancestor×2: 2 generations cleared close together, K011251 (2001), K013355 (2001) ×2: 2 generations cleared close together, K020663 (2002), K021263 (2002) K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalledK070065 · Ams Single Incision Sling System (Sis-0) · American Medical Systems, Inc. · 2007K071902 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2007K073703 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2008K121562 · Altis Single Incision Cling System · Coloplast A/S · 2012K221874 · Altis Single Incision Sling System · Coloplast A/S · 20231995200020052010201520202025
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors K221874 · Altis Single Incision Sling System · Coloplast A/S · 2023K121562 · Altis Single Incision Cling System · Coloplast A/S · 2012K073703 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2008K071902 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2007K070065 · Ams Single Incision Sling System (Sis-0) · American Medical Systems, Inc. · 2007K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalledK021263 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K020663 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K011251 · Sparc Sling System · American Medical Systems, Inc. · 2001−10−50
  1. Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 6 generations between
  3. 3 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  4. 2 generations backK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
  5. 1 generation backK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
  6. This deviceK242473 Altis Single Incision Sling System (519650); Aris Transobturator…Coloplast Corp. · 2024
Show all 10 generations
  1. Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 9 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 8 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 7 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 6 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. 5 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
  7. 4 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
  8. 3 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  9. 2 generations backK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
  10. 1 generation backK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
  11. This deviceK242473 Altis Single Incision Sling System (519650); Aris Transobturator…Coloplast Corp. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−9K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−8K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−7K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−6K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
−5K070065Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc.2007—
−4K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2007—
−3K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2008—
−2K121562Altis Single Incision Cling SystemColoplast A/S2012—
−1K221874Altis Single Incision Sling SystemColoplast A/S2023—
0 (this device)K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System…Coloplast Corp.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200410
200520
200910
201110
FIG. 1 — Lineage of K242473, 2001–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221874 Altis Single Incision Sling Systemscore 10.3 · 9 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K221874Altis Single Incision Sling System
Summary page 6
…OTN OTN 510(k) Coloplast A/S Coloplast A/S Coloplast A/S Submitter/Holder: 510(k) #/ Clearance K221874 K050148 K111233 Date Cleared 02/15/2023 Cleared 03/09/2005…
Coloplast A/S2023—
*K050148Mentor Aris Trans-Obturator Tape and Surgical Kit
Summary page 6
…OTN 510(k) Coloplast A/S Coloplast A/S Coloplast A/S Submitter/Holder: 510(k) #/ Clearance K221874 K050148 K111233 Date Cleared 02/15/2023 Cleared 03/09/2005 Cleared 06/24/2011 No r…
Mentor Corporation2005—
*K111233Supris Retropubic Sling System
Summary page 6
…Coloplast A/S Coloplast A/S Coloplast A/S Submitter/Holder: 510(k) #/ Clearance K221874 K050148 K111233 Date Cleared 02/15/2023 Cleared 03/09/2005 Cleared 06/24/2011 No reference devices were used…
Coloplast A/S2011—

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 23 years and passes through 3 companies; a new generation was cleared every 6 months on median.
  • 1 of the 17 ancestors has a recall of any class.

How does its category compare?

All PAH devices

PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · PAH

1in 2024

2007: 22008: 32009: 22010: 12011: 12012: 42020: 12023: 12024: 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAH

128in 2012

2008: 61 days median2012: 128 days median
2007high 128 (2012) · low 61 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PAH

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PAH

242in 2025

2010: 12011: 72012: 1292013: 2,3862014: 3382015: 2752016: 6972017: 1272018: 1742019: 2982020: 1712021: 3182022: 1592023: 1542024: 2872025: 242
2007high 2,386 (2013) · low 0 (2007)2025

MAUDE reports naming product code PAH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200836100
20092—00
20101—01
20111—07
201241280129
20130—02,386
20140—0338
20150—1275
20160—0697
20170—0127
20180—0174
20190—0298
20201—0171
20210—0318
20220—0159
20231—0154
20241—0287
20250—0242
20260—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 (ISO). The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary…

Read the full statement (123 words)

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 (ISO).

The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Indications for use as stated in the FDA summary.

More from Coloplast Corp.

143 FDA decisions under this applicant name. See the company

  • P000006/S076Titan Inflatable Penile ProsthesisColoplast Corp. · 2026
  • P020003/S012Torosa Saline Filled Testicular ProsthesisColoplast Corp. · 2026
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  • P000006/S072Titan Inflatable Penile Prosthesis (IPP)Coloplast Corp. · 2026

Recent decisions in PAH

The PAH category page

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc. · 2020
  • K121562Altis Single Incision Cling SystemColoplast A/S · 2012
  • K123179Ajust Helical Adjustable Single-Incision SlingC.R. Bard, Inc. · 2012
  • K121641Miniarc Pro Single-Incision Sling SystemAmerican Medical Systems · 20121 recall

https://510kreport.com/device/K242473 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242473: Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242473

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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