# K152088: IV-eye

- Pathway: 510(k) (Traditional)
- Applicant: Novarix Limited
- Decided: Feb 24, 2016 after 212 days
- Product code: KZA (Device, Vein Location, Liquid Crystal)
- Device class: 1
- Regulation: 21 CFR 880.6970
- 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 K042679 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042679: IR Viewer, Infrared Imaging Systems, Inc. (2004) Summary page 5.
- K101838: VTS1000, Vuetek Scientific, LLC (2011) Summary page 5.

## Indications for use
The IV-eye is a hand-held, non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture. The IV-eye should only be used in conjunction with standard techniques of visualization and palpation in assessing and locating veins. The IV-eye is intended only for skin contact via a disposable single use cover.

Source page: https://510kreport.com/device/K152088
Methodology: https://510kreport.com/methodology