Clearance Summary
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) received FDA 510(k) clearance under submission number K260239, sponsored by Jiangxi AOV Maternity & Baby Products 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 2026-04-22.
- Submission: K260239
- Applicant / Sponsor: Jiangxi AOV Maternity & Baby Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2026-04-22
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.