# K961327: Bec Needleless Injection Site

- Pathway: 510(k) (Traditional)
- Applicant: Biological & Environmental Control Laboratories
- Decided: May 15, 1996 after 37 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K944320 (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)
- K953343: Needleless Injection Site, Medical Associates Network, Inc. (1995) Summary page 1.
- K944320: Vented/Non-Vented Gemini Administration Set, Imed Corp. (1995) Summary page 1.

## Indications for use
The Needleless injection Site is intended to provide additional protection against inadvertent "needlestick” injuries to health care providers during the administration of fluids and rmedications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needie by allowing for the use of a blunt cannula.

Source page: https://510kreport.com/device/K961327
Methodology: https://510kreport.com/methodology