# K212180: Wearable Breast Pump (Model S12)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen TPH Technology Co., Ltd.
- Decided: Feb 11, 2022 after 214 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: 8 generations back to K801862 (1980). 12 ancestors in all.
25 later devices descend from it; 10 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191577: Willow Wearable Breast Pump 2.0, Exploramed Nc7, Inc. (2019) Summary page 4.

## Most influential descendants
- K242850: Wearable breast pump (model W8) (2025), 8 descendants of its own
- K240536: Wearable Breast Pump (Model S32) (2024), 2 descendants of its own
- K252420: Wearable Breast Pump (Model W12) (2026), 1 descendant of its own
- K250383: Wearable Breast Pump (Model W6) (2025), 1 descendant of its own
- K250843: Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (2025), 1 descendant of its own

## Indications for use
The Wearable Breast Pump (Model S12) 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/K212180
Methodology: https://510kreport.com/methodology