# K191802: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Huiyoo Baby Products Co., Ltd.
- Decided: Jan 16, 2020 after 197 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 K875300 (1988). 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)
- K151284: Electric Double Breast Pumps, Wuxi Xinzhongrui Baby Supplies Co., Ltd. (2015) Summary page 5.

## Indications for use
The Electric Breast Pumps are intended to express and collect milk from the breast of a lactating woman.

Source page: https://510kreport.com/device/K191802
Methodology: https://510kreport.com/methodology