# K042679: IR Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Infrared Imaging Systems, Inc.
- Decided: Dec 10, 2004 after 72 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ESP7 (Ironmaster): named in the summary without a submission number
- (no number) Venoscope (Trinity Partners): named in the summary without a submission number

## Most influential descendants
- K152088: IV-eye (2016), 0 descendants of its own

## Indications for use
The IR Viewer is a non-invasive, electronic device for visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. It is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.

Source page: https://510kreport.com/device/K042679
Methodology: https://510kreport.com/methodology