# K971500: Access Systems Needleless Vial Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Biological & Environmental Control Laboratories
- Decided: Aug 18, 1997 after 116 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944320: Vented/Non-Vented Gemini Administration Set, Imed Corp. (1995) Summary page 1.

## Indications for use
The risk to health care providers of "needlestick" injuries has become a major public health and worker safety concern. The Needleless Vial Adapter is intended to provide additional protection against inadvertent "needlestick” injuries to health care providers during the administration of fluids-and medications. The Needleless Vial Adapter provides for the entry into a stoppered vial without the need of a sharp needle by allowing for the use of a blunt cannula.

Source page: https://510kreport.com/device/K971500
Methodology: https://510kreport.com/methodology