# K212564: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd.
- Decided: May 6, 2022 after 266 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 K850705 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181784: Spectra S3 Plus, Uzinmedicare Co. (2018) Summary page 4.

## Indications for use
The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breasts, to alleviate engorgement of the breasts, maintain the ability of lactation, and provide mother’s milk for future feedings when separation of mother and baby occurs. This electric breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

Source page: https://510kreport.com/device/K212564
Methodology: https://510kreport.com/methodology