# K954064: Becton Dickinson Syringse

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Nov 21, 1995 after 83 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Single Use Hypodermic Syringes: named in the summary without a submission number

## Most influential descendants
- K071108: Texium Syringe (2007), 11 descendants of its own
- K083152: Equashield System (2009), 9 descendants of its own
- K091389: Equalshield Luer Lock Connector Pair (2009), 8 descendants of its own
- K101940: Equashield System Protective Plus (2010), 7 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own

Source page: https://510kreport.com/device/K954064
Methodology: https://510kreport.com/methodology