# K193449: Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd.
- Decided: Sep 11, 2020 after 273 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: 7 generations back to K801862 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182413: Electric Breast Pump, Guangdong Horigen Mother & Baby Products Co., Ltd. (2019) Summary page 4.

## Indications for use
The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053 01) are 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 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053 01) are intended for a single user.

Source page: https://510kreport.com/device/K193449
Methodology: https://510kreport.com/methodology