Clearance Summary
Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) received FDA 510(k) clearance under submission number K250843, sponsored by Shenzhen TPH Technology Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-07-31.
- Submission: K250843
- Applicant / Sponsor: Shenzhen TPH Technology Co., Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2025-07-31
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.