# K143585: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Xinghe Electrical Apparatuses Co., Ltd.
- Decided: May 6, 2015 after 139 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: 5 generations back to K801862 (1980). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122474: Lansinoh Powered Electric Breast Pump, Lansinoh Laboratories Saglik Gerecleri Tasarim San (2012) Summary page 4.

## Most influential descendants
- K182413: Electric Breast Pump (2019), 1 descendant of its own
- K193449: Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) (2020), 0 descendants of its own

## Indications for use
The electric breast pump is intended to express and collect milk 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 a single user, not for hospital use.

Source page: https://510kreport.com/device/K143585
Methodology: https://510kreport.com/methodology