Cleared Traditional

IRRIS (Infra-Red-Red Intubation System) (K171411) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171411 · A.R Guide IN Medical , Ltd. · Anesthesiology device
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Jan 2018
Decision
242d
Days
Class 2
Risk

K171411 is an FDA 510(k) clearance for the IRRIS (Infra-Red-Red Intubation System). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by A.R Guide IN Medical , Ltd. (Nazareth, IL). The FDA issued a Cleared decision on January 12, 2018 after a review of 242 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all A.R Guide IN Medical , Ltd. devices

Submission Details

510(k) Number K171411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date January 12, 2018
Days to Decision 242 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 140d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Medicsense USA
George J. Hattub

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 38
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K171411.
Frova Intubating Introducer
K171917 · Cook Incorporated · Apr 2018
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
K172208 · Nevap, Inc. · Feb 2018
Endotracheal tube
K170234 · Zhanjiang Star Enterprise Co., Ltd. · Jan 2018
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
K151381 · Covidien · Dec 2015
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · Covidien · Apr 2009
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008