Clearance Summary
Portable Oxygen Concentrator (Spirit-3) received FDA 510(k) clearance under submission number K242736, sponsored by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-06-05.
- Submission: K242736
- Applicant / Sponsor: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2025-06-05
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.