K252583
- 510(k) number
- K252583
- Device name
- Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
- Applicant
- A Cute Baby, Inc. UT · US
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-03-12
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252583.pdf
Official FDA record: K252583
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.