About This 510(k) Submission
K253934 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Shenzhen Root Innovation Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 9, 2026, 90 days after receiving the submission on December 9, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.