K231969 is an FDA 510(k) clearance for the BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Dongguanshi Yiyingmei Technology Co., Ltd. (Donguang, CN). The FDA issued a Cleared decision on August 30, 2024, 424 days after receiving the submission on July 3, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K231969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2023 |
| Decision Date | August 30, 2024 |
| Days to Decision | 424 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 |