Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K252583 · 2026-03-12

ApplicantA Cute Baby, Inc.
Decision Date2026-03-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) is a medical device manufactured by A Cute Baby, Inc.. It received FDA 510(k) clearance on 2026-03-12 under approval number K252583. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by A Cute Baby, Inc.. The 510(k) number is K252583.

When was Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) approved by the FDA?

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) received FDA 510(k) clearance on 2026-03-12, under approval number K252583.

What company makes Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) is manufactured by A Cute Baby, Inc..

What is the FDA product code for Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

The FDA product code for Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) is HGX.

Related Clinical Trials

NCT05746325 Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer RECRUITING

Other Devices by A Cute Baby, Inc.

K200712Rumble Tuff Electric Breast Pump

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑