# HGX: Pump, Breast, Powered

- Device class: 2; regulation: 21 CFR 884.5160; FDA's rule: 510(k) required
- FDA decisions: 254
- 510(k) review time 2021–2025: median 154 days (middle half 115–222)
- Recalls: 7 (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: 8
- 2018: 6
- 2019: 7
- 2020: 9
- 2021: 12
- 2022: 15
- 2023: 15
- 2024: 19
- 2025: 26
- 2026: 34

## Most-cited predicates
- K973501: Expresse and Premier Powered Breast Pumps (1997), cited by 13
- K212180: Wearable Breast Pump (Model S12) (2022), cited by 10
- K950750: Medelas Breast Pump (1995), cited by 9
- K242850: Wearable breast pump (model W8) (2025), cited by 7
- K241322: Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (2024), cited by 7
- K031614: Medela Pump in Style Advanced Breast Pump (2003), cited by 7
- K020518: Medela Symphony Breast Pump, Model 024 (2002), cited by 6
- K150476: Spectra S1Plus and Spectra S2 Plus (2016), cited by 6
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (2015), cited by 6
- K053052: Medela Swing Breast Pump (2006), cited by 5

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