Clearance Summary
PIVO Pro Needle-free Blood Collection Device received FDA 510(k) clearance under submission number K241586, sponsored by Becton Dickinson Infusion Therapy Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2025-02-27.
- Submission: K241586
- Applicant / Sponsor: Becton Dickinson Infusion Therapy Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2025-02-27
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.