Cleared Traditional

BD Vacutainer? One Use Holder

K242320 · Becton, Dickinson and Company · General Hospital
Nov 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K242320 is an FDA 510(k) clearance for the BD Vacutainer? One Use Holder, 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 November 1, 2024, 88 days after receiving the submission on August 5, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K242320 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date November 01, 2024
Days to Decision 88 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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