# K242850: Wearable breast pump (model W8)

- Pathway: 510(k) (Abbreviated)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Feb 21, 2025 after 154 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: 9 generations back to K801862 (1980). 13 ancestors in all.
8 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212180: Wearable Breast Pump (Model S12), Shenzhen TPH Technology Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K252420: Wearable Breast Pump (Model W12) (2026), 1 descendant of its own
- K254203: Wearable Breast Pump (Model S36) (2026), 0 descendants of its own
- K262774: Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (2026), 0 descendants of its own
- K254244: Wearable Breast Pump (Model S39) (2026), 0 descendants of its own
- K252422: Wearable Breast Pump (Model W2) (2026), 0 descendants of its own

## Indications for use
The Wearable Breast Pump (Model W8) 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/K242850
Methodology: https://510kreport.com/methodology