# Hygeia II Medical Group, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 4 (2019–2024): 4 510(k) clearances
- Product codes: HGX (4)
- 510(k) review time since 2016: median 174 days, against 163 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hygeia Medical, Inc.: 1 (https://510kreport.com/company/hygeia-medical)
- Ameda, Inc.: 1 (https://510kreport.com/company/ameda)
- Shantou Huihengqi Electronic Technology Co., Ltd.: 1 (https://510kreport.com/company/shantou-huihengqi-electronic-technology)

## Its most-cited devices
- K190465: Evolve Breast Pump (2019), cited by 1

## Recent decisions
- K233136: Hygeia Express Powered Breast Pump (Mar 13, 2024)
- K212955: Fit Pro Breast Pump (Mar 15, 2022)
- K200406: Evolve Breast Pump (Mar 18, 2020)
- K190465: Evolve Breast Pump (Oct 18, 2019)

Source page: https://510kreport.com/company/hygeia-ii-medical-group