Cleared Special

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

K253283 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology
Oct 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K253283 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-), 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 October 29, 2025, 30 days after receiving the submission on September 29, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K253283 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date October 29, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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