# K223886: Wearable Breast Pump (Model S18)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Jul 14, 2023 after 199 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 4.

## Most influential descendants
- 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; (2025), 0 descendants of its own

## Indications for use
The Wearable Breast Pump (Model S18) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Source page: https://510kreport.com/device/K223886
Methodology: https://510kreport.com/methodology