# K261025: Wearable breast pump (QY-101, QY-102, QY-108)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Qinyi Electronic Technology Co., Ltd.
- Decided: Jun 25, 2026 after 87 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: 7 generations back to K801862 (1980). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243508: Wearable breast pump (model S12A), Shenzhen TPH Technology Co., Ltd. (2025) Summary page 6.

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

Source page: https://510kreport.com/device/K261025
Methodology: https://510kreport.com/methodology