# K013950: Vented Vial Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Jan 10, 2002 after 41 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 K003730 (2000). 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)
- K003730: Chemo-Aide Dispensing Pin, Baxter Healthcare Corp (2000) Summary page 1.

## Indications for use
Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

Source page: https://510kreport.com/device/K013950
Methodology: https://510kreport.com/methodology