# K961328: Bec Shrouded Plastic Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Biological & Environmental Control Laboratories
- Decided: May 30, 1996 after 52 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945070 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952834: Shrouded Plastic Cannula, Medical Associates Network, Inc. (1995) Summary page 1.
- K945070: Versasae Plastic Cannula- 11 Gauge, Imed Corp. (1995) Summary page 1.

## Indications for use
The Shrouded Plastic Cannula is intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the administration of fluids and medications. The Shrouded Plastic Cannula provides the ability to penetrate a split septum injection site or Y-site for entry into a intravascular system without the need of a sharp needle.

Source page: https://510kreport.com/device/K961328
Methodology: https://510kreport.com/methodology