# K250843: Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

- Pathway: 510(k) (Special)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Jul 31, 2025 after 133 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.
1 later device descends from it; 1 cites it directly.
0 of 15 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
- K260346: Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) (2026), 0 descendants of its own

## Indications for use
The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user only.

Source page: https://510kreport.com/device/K250843
Methodology: https://510kreport.com/methodology