# K251754: Wearable Breast Pump (Model S33)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Sep 8, 2025 after 91 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)
- K242850: Wearable breast pump (model W8), Shenzhen TPH Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
The Wearable Breast Pump (Model S33) 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/K251754
Methodology: https://510kreport.com/methodology