# Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 4 (2024–2026): 4 510(k) clearances
- Product codes: HGX (4)
- 510(k) review time since 2016: median 107 days, against 132 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 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
- Ningbo Youhe Electrical Appliance Technology Co., Ltd.: 1 (https://510kreport.com/company/ningbo-youhe-electrical-appliance-technology)

## Its most-cited devices
- K240218: Electric Breast Pump (F5055) (2024), cited by 2
- K252629: Electric Breast Pump (HL-3058, F5112) (2025), cited by 1

## Recent decisions
- K254125: Electric Breast Pump (HL-3058 II Pro) (May 13, 2026)
- K252629: Electric Breast Pump (HL-3058, F5112) (Oct 27, 2025)
- K252630: Electric Breast Pump (HL-3060, F5113) (Oct 27, 2025)
- K240218: Electric Breast Pump (F5055) (Oct 17, 2024)

Source page: https://510kreport.com/company/fimilla-shanghai-maternity-baby-articles