# K051930: Drug Access Spike

- Pathway: 510(k) (Traditional)
- Applicant: Medegen Medical Manufacturing Services
- Decided: Aug 16, 2005 after 34 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K894177 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934591: Clave Vial Access Spike, Icu Medical, Inc. (1994) Summary page 1.
- K934561: One Time Vial Access Spike, Icu Medical, Inc. (1994) Summary page 1.
- K894177: Needle*Less Drug Vial Adapter, Baxter Healthcare Corp (1989) Summary page 1.

## Indications for use
The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

Source page: https://510kreport.com/device/K051930
Methodology: https://510kreport.com/methodology