# K974363: Becton Dickinson Blunt Plastic Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jun 3, 1998 after 196 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854547 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964654: Becton Dickinson Blunt Plastic Cannula, Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 1.

## Most influential descendants
- K013949: Universal Vial Access Spike with Needleless Connector (2002), 0 descendants of its own

## Recalls of this device
- Dec 19, 2014 · Class II · Z-1055-2015: The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
- Jun 21, 2006 · Not classified · Z-1461-06: Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

## Indications for use
The B-De Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penetration with needieless IV access cannula. The B-De Biunt Plastic Cannula provides access to fiuid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-siit injection sites.

Source page: https://510kreport.com/device/K974363
Methodology: https://510kreport.com/methodology