Cleared Abbreviated

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

K252583 · A Cute Baby, Inc. · Obstetrics & Gynecology

Mar 2026

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K252583 is an FDA 510(k) clearance for the Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by A Cute Baby, Inc. (Orem, US). The FDA issued a Cleared decision on March 12, 2026, 209 days after receiving the submission on August 15, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K252583 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2025
Decision Date	March 12, 2026
Days to Decision	209 days
Submission Type	Abbreviated
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF