Clearance Summary
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) received FDA 510(k) clearance under submission number K231969, sponsored by Dongguanshi Yiyingmei Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2024-08-30.
- Submission: K231969
- Applicant / Sponsor: Dongguanshi Yiyingmei Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2024-08-30
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.