Cleared Traditional

BD Vacutainer? Multiple Sample Luer Adapter

K243649 · Becton, Dickinson and Company · General Hospital
Mar 2025
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K243649 is an FDA 510(k) clearance for the BD Vacutainer? Multiple Sample Luer Adapter, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on March 21, 2025, 115 days after receiving the submission on November 26, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K243649 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2024
Decision Date March 21, 2025
Days to Decision 115 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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