# K231595: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changkun Technology Co., Ltd.
- Decided: Oct 26, 2023 after 147 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250070: Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (2026), 0 descendants of its own

## Indications for use
The Electric Breast Pump is 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/K231595
Methodology: https://510kreport.com/methodology