# OMP: Negative Pressure Wound Therapy Powered Suction Pump

- Device class: 2; regulation: 21 CFR 878.4780; FDA's rule: 510(k) required
- FDA decisions: 217
- 510(k) review time 2021–2025: median 250 days (middle half 136–351)
- Recalls: 23 (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)
- 2017: 11
- 2018: 13
- 2019: 15
- 2020: 6
- 2021: 9
- 2022: 10
- 2023: 8
- 2024: 9
- 2025: 5
- 2026: 9

## Most-cited predicates
- K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats (2003), cited by 14
- K042134: Versatile 1 Wound Vacuum System (2004), cited by 10
- K092992: A4-XLR8 Foam Dressing (2010), cited by 8
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), cited by 8
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys (2011), cited by 7
- K080357: Medela Invia Wound Therapy (2008), cited by 7
- K142979: RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters (2015), cited by 6
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), cited by 6
- K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit (2012), cited by 6
- K100821: Prevena Incision Management System (2010), cited by 6

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