# K252422: Wearable Breast Pump (Model W2)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Feb 13, 2026 after 196 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.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242850: Wearable breast pump (model W8), Shenzhen TPH Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
The Wearable Breast Pump (Model W2) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Source page: https://510kreport.com/device/K252422
Methodology: https://510kreport.com/methodology