# OKO: Negative Pressure Wound Therapy Non-Powered Suction Apparatus

- Device class: 2; regulation: 21 CFR 878.4683; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 30 days (middle half 29–66)
- Recalls: 0 (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)
- 2009: 1
- 2011: 4
- 2014: 3
- 2015: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2024: 2
- 2025: 2
- 2026: 1

## Most-cited predicates
- K151710: SNaP Wound Care System (2015), cited by 4
- K111393: Snap (R) Wound Care System (2011), cited by 3
- DEN080011: Snap Wound Care Device (2009), cited by 3
- K132080: Snap Wound Care System (2014), cited by 2
- K112341: Snap Wound Care System (2011), cited by 2
- K212971: NPseal (2022), cited by 1
- K200305: NPseal (2020), cited by 1
- K240244: NPseal (Small, Medium, Large) (2024), cited by 1
- K142272: SNaP Wound Care System (2014), cited by 1
- K211130: NPseal (2021), cited by 1

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