# K080989: Universal Vial Access Spike

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: May 2, 2008 after 25 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934561 (1994). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934561: One Time Vial Access Spike, Icu Medical, Inc. (1994) Summary page 1.
- K934591: Clave Vial Access Spike, Icu Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K192866: Chemfort CSTD (2020), 3 descendants of its own
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0710-2021: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous me

## Indications for use
Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.

Source page: https://510kreport.com/device/K080989
Methodology: https://510kreport.com/methodology