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)— 510(k) K241705

Substantially Equivalent

Milkmate Products, Inc.

FDA 510(k) clearance K241705 for 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), Substantially Equivalent on 2024-07-12. Applicant: Milkmate Products, Inc..

Clearance details

Applicant: Milkmate Products, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2024-06-13
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.