# K211016: Powered Breast Pump (Models 7V and 7X)

- Pathway: 510(k) (Traditional)
- Applicant: Haenim Co., Ltd.
- Decided: Jun 29, 2022 after 450 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)
- K200675: Hi bebe super (Models BT-150S and BT-150L), Bistos Co., Ltd. (2021) Summary page 4.

## Indications for use
The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K211016
Methodology: https://510kreport.com/methodology