Cleared Special

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

K250152 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology

Apr 2025

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K250152 is an FDA 510(k) clearance for the eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;, 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 April 2, 2025, 71 days after receiving the submission on January 21, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K250152 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2025
Decision Date	April 02, 2025
Days to Decision	71 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF