Clearance Summary
DEKA Infusion System, DEKA Administration Set received FDA 510(k) clearance under submission number K242693, sponsored by Deka Research and Development Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-10-07.
- Submission: K242693
- Applicant / Sponsor: Deka Research and Development Corporation
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2024-10-07
Classification & Regulation
This clearance is catalogued under FDA product code LDR and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.