# K082836: Icu Medical Universal Single-Use Spikes

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: Feb 25, 2009 after 152 days
- Product code: FMG (Stopcock, I.V. Set)
- 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: 1 generation back to K964435 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964435: Primary IV Set, Icu Medical, Inc. (1997) Summary page 1.

## Indications for use
Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non-pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.

Source page: https://510kreport.com/device/K082836
Methodology: https://510kreport.com/methodology