Cleared Traditional

BD Vacutainer? Plasma Separator Tubes (PST?), BD Vacutainer? Sodium Heparin Blood Collection Tubes

K252040 · Becton, Dickinson and Company · Chemistry
Mar 2026
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K252040 is an FDA 510(k) clearance for the BD Vacutainer? Plasma Separator Tubes (PST?), BD Vacutainer? Sodium Heparin Blood Collection Tubes, 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 13, 2026, 256 days after receiving the submission on June 30, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K252040 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2025
Decision Date March 13, 2026
Days to Decision 256 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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