Clearance Summary
Electric Breast Pump (HL-3058, F5112) received FDA 510(k) clearance under submission number K252629, sponsored by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. 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 2025-10-27.
- Submission: K252629
- Applicant / Sponsor: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2025-10-27
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.