# K243508: Wearable breast pump (model S12A)

- Pathway: 510(k) (Abbreviated)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Apr 21, 2025 after 160 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: 6 generations back to K801862 (1980). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213311: Lucy Breast Pump, Willow Innovations, Inc. (2022) Summary page 5.

## Most influential descendants
- K261025: Wearable breast pump (QY-101, QY-102, QY-108) (2026), 0 descendants of its own

## Indications for use
The Wearable Breast Pump (Model S12A) 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/K243508
Methodology: https://510kreport.com/methodology