# K041232: Gettig Universal Vial Access Pin

- Pathway: 510(k) (Traditional)
- Applicant: Gettig Pharmaceutical Instrument Co.
- Decided: Jul 22, 2004 after 73 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 2 generations back to K790472 (1979). 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)
- K013087: Single Dose Dispensing Pin, Model 2201, Alaris Medical Systems, Inc. (2001) Summary page 1.
- K853212: Flow Ease (Plastic Vented Needle), Acacia, Inc. (1985) Summary page 1.

## Indications for use
The intended use of the Gettig Universal Vial Access Pin is to pierce the diaphragm of single or multi-dose vials to inject or withdraw fluids without the use of a needle. The Gettig Universal Vial Access Pin is indicated for use with standard medication vials.

Source page: https://510kreport.com/device/K041232
Methodology: https://510kreport.com/methodology