510(k) K241705

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) by Milkmate Products, Inc. — Product Code HGX

K241705 is an FDA 510(k) premarket notification submitted by Milkmate Products, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on July 12, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Milkmate Products, Inc. has at least 1 other 510(k) clearance on record.