Cleared Special

Ameda GLO Wearable Breast Pump (Model W8S)

K250463 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250463 is an FDA 510(k) clearance for the Ameda GLO Wearable Breast Pump (Model W8S), 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 March 20, 2025, 30 days after receiving the submission on February 18, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K250463 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2025
Decision Date March 20, 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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