Cleared Traditional

K151433 - AUDICOR CA300/CC100 Analyzer with SDB (FDA 510(k) Clearance)

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

K151433 · Inovise Medical, Inc. · Anesthesiology device
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Mar 2016
Decision
295d
Days
Class 2
Risk

K151433 is an FDA 510(k) clearance for the AUDICOR CA300/CC100 Analyzer with SDB. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Beaverton, US). The FDA issued a Cleared decision on March 18, 2016 after a review of 295 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Inovise Medical, Inc. devices

Submission Details

510(k) Number K151433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date March 18, 2016
Days to Decision 295 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
156d slower than avg
Panel avg: 139d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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.