Clearance Summary
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) received FDA 510(k) clearance under submission number K252583, sponsored by A Cute Baby, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-03-12.
- Submission: K252583
- Applicant / Sponsor: A Cute Baby, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2026-03-12
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.