# K240218: Electric Breast Pump (F5055)

- Pathway: 510(k) (Traditional)
- Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
- Decided: Oct 17, 2024 after 265 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801862 (1980). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163136: Youha electric breast pump, Ningbo Youhe Electrical Appliance Technology Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K252629: Electric Breast Pump (HL-3058, F5112) (2025), 1 descendant of its own
- K254125: Electric Breast Pump (HL-3058 II Pro) (2026), 0 descendants of its own
- K252630: Electric Breast Pump (HL-3060, F5113) (2025), 0 descendants of its own

## Indications for use
The Electric Breast Pump (F5059) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

Source page: https://510kreport.com/device/K240218
Methodology: https://510kreport.com/methodology