# K252630: Electric Breast Pump (HL-3060, F5113)

- Pathway: 510(k) (Traditional)
- Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
- Decided: Oct 27, 2025 after 68 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: 7 generations back to K801862 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240218: Electric Breast Pump (F5055), Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. (2024) Summary page 5.

## Indications for use
The Electric Breast Pump (Models HL-3060, F5113) 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/K252630
Methodology: https://510kreport.com/methodology