510(k) · Cleared
ClearedAjust Adjustable Single Incision Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Nov 20, 2009 after an 87-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 20, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK092607 Ajust Adjustable Single Incision SlingC.R. Bard, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK121562 Altis Single Incision Cling SystemColoplast A/S · 2012
- Descendant · 2 generations on · 1 of its ownK221874 Altis Single Incision Sling SystemColoplast A/S · 2023
- Descendant · 3 generations on · 0 of its ownK242473 Altis Single Incision Sling System (519650); Aris Transobturator…Coloplast Corp. · 2024
- Descendant · cites it directly · 0 of its ownK123179 Ajust Helical Adjustable Single-Incision SlingC.R. Bard, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K121562Altis Single Incision Cling SystemColoplast A/S · 2012 · cites it directly2descendants
- K221874Altis Single Incision Sling SystemColoplast A/S · 2023 · 2 generations on1descendant
- K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…Coloplast Corp. · 2024 · 3 generations on0descendants
- K123179Ajust Helical Adjustable Single-Incision SlingC.R. Bard, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092607 | Ajust Adjustable Single Incision Sling | C.R. Bard, Inc. | 2009 | — |
| +1 | K121562 | Altis Single Incision Cling System | Coloplast A/S | 2012 | — |
| +2 | K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023 | — |
| +3 | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System… | Coloplast Corp. | 2024 | — |
| +1 | K123179 | Ajust Helical Adjustable Single-Incision Sling | C.R. Bard, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | — | Align® Urethral Support System Named without a submission number | |
| * | — | Tissue Fixation System Sling Named without a submission number | |
| * | — | MiniArc™ Sling System Named without a submission number | |
| * | — | IVS Tunneller™ System Named without a submission number | |
| * | — | Elevate™ Prolapse Repair System Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K121562 (Coloplast A/S, 2012) has gone furthest, with 2 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. 2009, 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 Ajust™ Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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/K092607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092607: Ajust Adjustable Single Incision Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092607
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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