Cleared Abbreviated

Mini Moon electric breast pump (PA221) (K252583) - FDA 510(k) Clearance

Also marketed or referenced as:
Moon Wave electric breast pump (PA220)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K252583 · A Cute Baby, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
209d
Days
Class 2
Risk

K252583 is an FDA 510(k) clearance for the Mini Moon electric breast pump (PA221). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by A Cute Baby, Inc. (Orem, US). The FDA issued a Cleared decision on March 12, 2026 after a review of 209 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all A Cute Baby, Inc. devices

Submission Details

510(k) Number K252583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 160d · This submission: 209d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K252583.
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
K253946 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
SPECTRA Wearable 2
K250208 · Uzinmedicare Co., Ltd. · Apr 2026
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
K252744 · Cixi Ruihong Electric Appliance Co., Ltd. · Apr 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