# K233136: Hygeia Express Powered Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Hygeia II Medical Group, Inc.
- Decided: Mar 13, 2024 after 168 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: 8 generations back to K801862 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211024: Electric Breast Pump, Shantou Huihengqi Electronic Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.

Source page: https://510kreport.com/device/K233136
Methodology: https://510kreport.com/methodology