# K251394: Momcozy Wearable Breast Pump (BP223)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Root Innovation Technology Co., Ltd.
- Decided: Sep 8, 2025 after 126 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: 10 generations back to K801862 (1980). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241322: Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010), Joytech Healthcare Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K253283: Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (2025), 1 descendant of its own
- K254300: eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) (2026), 0 descendants of its own
- K253914: Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) (2026), 0 descendants of its own
- K253934: Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) (2026), 0 descendants of its own

## Indications for use
The Momcozy Wearable Breast Pump (Model: BP223) is a powered breast pump 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/K251394
Methodology: https://510kreport.com/methodology