Clearance Summary
eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) received FDA 510(k) clearance under submission number K250207, sponsored by Anker Innovations Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-08-11.
- Submission: K250207
- Applicant / Sponsor: Anker Innovations Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2025-08-11
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.