# K013949: Universal Vial Access Spike with Needleless Connector

- Pathway: 510(k) (Traditional)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Mar 27, 2002 after 117 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: 3 generations back to K854547 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974363: Becton Dickinson Blunt Plastic Cannula, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Indications for use
Churchill Medical Systems Vial Access Spike with Needleless Connector is used in L.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device eliminates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.

Source page: https://510kreport.com/device/K013949
Methodology: https://510kreport.com/methodology