# K974198: Taky-Spike Plus

- Pathway: 510(k) (Traditional)
- Applicant: Clinico
- Decided: Dec 22, 1997 after 42 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062482: Vented Vial Adapter Transfer Device (2006), 4 descendants of its own
- K160503: Vented Vial Adapter Transfer Device - 13mm (2016), 2 descendants of its own
- K221406: Vented Vial Transfer Pin (2022), 0 descendants of its own
- K213513: Vented Vial Adapter 20mm (2022), 0 descendants of its own
- K122265: Vialok Single Vial Access Device Vented (2012), 0 descendants of its own

## Indications for use
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Source page: https://510kreport.com/device/K974198
Methodology: https://510kreport.com/methodology