# OTM: Mesh, Surgical, For Stress Urinary Incontinence, Male

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 90 days (middle half 71–139)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 3
- 2008: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2018: 1
- 2021: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K053371: Ams Male Transobturator Sling System (2006), cited by 3
- K082640: Virtue Ventral Urethral Elevation Sling System (2008), cited by 2
- K101297: Virtue Ventral Urethral Elevation Sling System Model 50020 (2010), cited by 2
- K091152: Virtue Ventral Urethral Elevation Sling System, Model 50020 (2009), cited by 1
- K113496: Virture Male Sling System with Alexis Wound Retractor Convenience Kit (2012), cited by 1
- K211847: AdVance XP Male Sling System (2021), cited by 1
- K182169: AdVance XP Male Sling (2018), cited by 1

Source page: https://510kreport.com/product-code/OTM
Data by year (CSV): https://510kreport.com/product-code/OTM.csv