# K171411: IRRIS (Infra-Red-Red Intubation System)

- Pathway: 510(k) (Traditional)
- Applicant: A.R Guide IN Medical, Ltd.
- Decided: Jan 12, 2018 after 242 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- 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 K110962 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110962: Ambu Ascope 2, Ambu A/S (2011) Summary page 4.

## Indications for use
The IRRIS is intended for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices.

Source page: https://510kreport.com/device/K171411
Methodology: https://510kreport.com/methodology