Cleared Traditional

PIVO? Pro Needle-free Blood Collection Device

K241586 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Feb 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K241586 is an FDA 510(k) clearance for the PIVO? Pro Needle-free Blood Collection Device, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on February 27, 2025, 269 days after receiving the submission on June 3, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K241586 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2024
Decision Date February 27, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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