# K252192: Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

- Pathway: 510(k) (Special)
- Applicant: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
- Decided: Aug 13, 2025 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

Source page: https://510kreport.com/device/K252192
Methodology: https://510kreport.com/methodology