# K211024: Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Huihengqi Electronic Technology Co., Ltd.
- Decided: Feb 11, 2022 after 311 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.
3 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201903: Electric breast pump (Models: RH-228 and RH-338), Cixi Ruihong Electric Appliance Co., Ltd. (2021). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K252342: Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (2025), 0 descendants of its own
- K232477: Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) (2024), 0 descendants of its own
- K233136: Hygeia Express Powered Breast Pump (2024), 0 descendants of its own

## Indications for use
The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.

Source page: https://510kreport.com/device/K211024
Methodology: https://510kreport.com/methodology