Cleared Traditional

CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V (K082038) - FDA 510(k) Clearance

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

K082038 · Clarus Medical, LLC · Anesthesiology device
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Apr 2009
Decision
285d
Days
Class 2
Risk

K082038 is an FDA 510(k) clearance for the CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Clarus Medical, LLC (Golden Valley, US). The FDA issued a Cleared decision on April 28, 2009 after a review of 285 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 Clarus Medical, LLC devices

Submission Details

510(k) Number K082038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date April 28, 2009
Days to Decision 285 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 140d · This submission: 285d
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 Peers - BTR Tube, Tracheal (w/wo Connector)

All 40
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K082038.
Endotracheal tube
K170234 · Zhanjiang Star Enterprise Co., Ltd. · Jan 2018
IRRIS (Infra-Red-Red Intubation System)
K171411 · A.R Guide IN Medical , 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
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · C.R. Bard, Inc. · Nov 2007