Cleared Traditional

Motif Aura Glow breast pump (Model Motif Aura Glow)

K250365 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
May 2025
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K250365 is an FDA 510(k) clearance for the Motif Aura Glow breast pump (Model Motif Aura Glow), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Shenzhen TPH Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 30, 2025, 109 days after receiving the submission on February 10, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K250365 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2025
Decision Date May 30, 2025
Days to Decision 109 days
Submission Type Traditional
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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