Clearance Summary
5008X Hemodialysis System received FDA 510(k) clearance under submission number K231534, sponsored by Fresenius Medical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-02-02.
- Submission: K231534
- Applicant / Sponsor: Fresenius Medical Care
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2024-02-02
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.