K252342 is an FDA 510(k) clearance for the Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Guangdong Youmeng Electrical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on December 19, 2025, 144 days after receiving the submission on July 28, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K252342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 144 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 |