# K132882: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Xinghe Electrical Apparatuses Co., Ltd.
- Decided: Apr 24, 2014 after 223 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: 3 generations back to K801862 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100435: Ameda Platinum Breast Pump, Evenflo Company, Inc. (2010) Summary page 3.

## Indications for use
The electric breast pump is to express and collect milk from breast from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for single user.

Source page: https://510kreport.com/device/K132882
Methodology: https://510kreport.com/methodology