Cleared Special

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

K243629 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology

Dec 2024

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K243629 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430), 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 December 20, 2024, 25 days after receiving the submission on November 25, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K243629 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2024
Decision Date	December 20, 2024
Days to Decision	25 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement