K252583 is an FDA 510(k) clearance for the Mini Moon electric breast pump (PA221). This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.5160.
| 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 |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |