# K251977: electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Youhe Electrical Appliance Technology Co., Ltd.
- Decided: Oct 22, 2025 after 117 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: 9 generations back to K801862 (1980). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231785: Perifit Pump, X6 Innovations (2024) Summary page 5.

## Indications for use
The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Source page: https://510kreport.com/device/K251977
Methodology: https://510kreport.com/methodology