# K250152: eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

- Pathway: 510(k) (Special)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Apr 2, 2025 after 71 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)
- K223886: Wearable Breast Pump (Model S18), Shenzhen TPH Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) are intended to express milk from lactating women in order to collect milk from their breasts. These devices are intended for a single user.

Source page: https://510kreport.com/device/K250152
Methodology: https://510kreport.com/methodology