Cleared Traditional

BD Vacutainer? Eclipse? Blood Collection Needle

K243207 · Becton, Dickinson and Company · General Hospital
Jul 2025
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K243207 is an FDA 510(k) clearance for the BD Vacutainer? Eclipse? Blood Collection Needle, 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 July 3, 2025, 275 days after receiving the submission on October 1, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K243207 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2024
Decision Date July 03, 2025
Days to Decision 275 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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