# K934561: One Time Vial Access Spike

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Feb 10, 1994 after 142 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
No predicates in its family tree.
28 later devices descend from it; 3 cite it directly.
4 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K080989: Universal Vial Access Spike (2008), 13 descendants of its own
- K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own
- K013087: Single Dose Dispensing Pin, Model 2201 (2001), 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

Source page: https://510kreport.com/device/K934561
Methodology: https://510kreport.com/methodology