510(k) K252344

BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) by Becton, Dickinson And Company — Product Code JKA

K252344 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton, Dickinson And Company has 330 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 16, 2026
Date Received
Jul 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type
510(k)

Source: FDA 510(k) database entry for K252344. Report a data issue: hello@regdatalab.com.