# K254125: Electric Breast Pump (HL-3058 II Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
- Decided: May 13, 2026 after 145 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: 8 generations back to K801862 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252629: Electric Breast Pump (HL-3058, F5112), Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. (2025) Summary page 5.

## Indications for use
The Electric Breast Pump (Model: HL-3058 II Pro) 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/K254125
Methodology: https://510kreport.com/methodology