Clearance Summary
MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) received FDA 510(k) clearance under submission number K241705, sponsored by Milkmate Products, Inc.. 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 2024-07-12.
- Submission: K241705
- Applicant / Sponsor: Milkmate Products, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2024-07-12
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.