K253934 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Shenzhen Root Innovation Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 9, 2026, 90 days after receiving the submission on December 9, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K253934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2025 |
| Decision Date | March 09, 2026 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| 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 |