K242725 is an FDA 510(k) clearance for the Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Ningbo Youhe Electrical Appliance Technology Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on May 30, 2025, 262 days after receiving the submission on September 10, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K242725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2024 |
| Decision Date | May 30, 2025 |
| Days to Decision | 262 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 |