Cleared Traditional

Wearable Breast Pump (Model S21)

K250368 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
May 2025
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K250368 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S21), 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 K250368 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

Similar Devices — HGX Pump, Breast, Powered

All 226
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
K252583 · A Cute Baby, Inc. · Mar 2026
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
K253934 · Shenzhen Root Innovation Technology Co., Ltd. · Mar 2026
Wearable Breast Pump (Model W12)
K252420 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Wearable Breast Pump (Model W2)
K252422 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Motion InBra (YM-8801) wearable breast pump
K253149 · Medela, LLC · Feb 2026
Spectra S1 Pro; Spectra S2 Pro
K251423 · Uzinmedicare Co., Ltd. · Feb 2026