IRRIS Infra-Red-Red Intubation System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171411 FDA 510(k)
- FDA Product Code
- BTR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5730 FDA 510(k)
- Regulation Number
- 868.5730 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IRRIS Infra-Red-Red Intubation System is a tracheal tube designed to assist in the visualisation and placement of endotracheal tubes during intubation procedures. It utilises infrared technology to enhance visibility of the tube within the airway, particularly in challenging clinical scenarios such as limited lighting or anatomical obstructions.
This system is intended for use in operating rooms and critical care settings by anaesthesiologists. Supplied as a single-use device, it is compatible with various tracheal tube sizes and connectors as listed in the regulatory filings. The device holds FDA 510(k) clearance and MDR authorisation, adhering to regulatory standards for medical devices in tracheal intubation. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What clinical scenarios is the IRRIS system designed to assist with during intubation procedures?
The IRRIS Infra-Red-Red Intubation System is specifically designed to enhance visualization of endotracheal tubes during intubation in challenging conditions, such as low-light environments or when anatomical obstructions may hinder clear visibility. It is intended for use in operating rooms and critical care settings, where precise tube placement is critical.
Is the IRRIS system reusable or intended for single-use only?
The IRRIS system is supplied as a single-use device, adhering to standard sterile medical device protocols. This ensures patient safety and reduces the risk of cross-contamination between procedures.
What tracheal tube sizes and connectors is the IRRIS system compatible with?
The IRRIS system is compatible with a wide range of tracheal tube sizes and connectors, as listed in the regulatory filings. These include various FEI numbers and registration numbers, covering multiple standard tracheal tube configurations for adult and pediatric use.
How should the IRRIS system be stored to maintain its integrity?
The IRRIS system should be stored following standard sterile medical device protocols. Since it is single-use, it should be kept in its original packaging until ready for immediate use, ensuring sterility and preventing contamination.
What regulatory pathways has the IRRIS system undergone for approval?
The IRRIS system holds FDA 510(k) clearance and MDR (Medical Device Regulation) authorization. These pathways confirm that the device meets regulatory standards for tracheal intubation aids in the United States and European Union markets, respectively.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171411 | Class II | Active |
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Manufacturer
- Manufacturer
- A.R Guide IN Medical , Ltd.
Sources (2)
- FDA 510(k) K171411 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026