# K201152: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd.
- Decided: May 4, 2021 after 370 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.
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)
- K181784: Spectra S3 Plus, Uzinmedicare Co. (2018) Summary page 4.

## Most influential descendants
- K223084: MilkMate Breast Pump (2023), 1 descendant of its own
- K241705: MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) (2024), 0 descendants of its own

## Indications for use
The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their 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. It is intended for a single user in a home or hospital environment.

Source page: https://510kreport.com/device/K201152
Methodology: https://510kreport.com/methodology