Cleared Special

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

K250843 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
Jul 2025
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K250843 is an FDA 510(k) clearance for the Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B), 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 July 31, 2025, 133 days after receiving the submission on March 20, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K250843 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2025
Decision Date July 31, 2025
Days to Decision 133 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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