510(k) K251350

BD Plastipak™ Syringe by Becton, Dickinson and Company — Product Code FMF

K251350 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Plastipak™ Syringe". The FDA issued a decision of Substantially Equivalent on July 29, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2025
Date Received
April 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type