# K243629: Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Root Innovation Technology Co.,, Ltd.
- Decided: Dec 20, 2024 after 25 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
The Momcozy Wearable Breast Pump (Model: BP311, BP223, BP324, BP334, BP430) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Source page: https://510kreport.com/device/K243629
Methodology: https://510kreport.com/methodology