Cleared Traditional

Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)

K253072 · Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. · Obstetrics & Gynecology

Dec 2025

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K253072 is an FDA 510(k) clearance for the Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025, 91 days after receiving the submission on September 23, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K253072 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2025
Decision Date	December 23, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF