K251394 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (BP223), 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 September 8, 2025, 126 days after receiving the submission on May 5, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K251394 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 2025 |
| Decision Date | September 08, 2025 |
| Days to Decision | 126 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 |