Cleared Traditional

K131883 - AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) (FDA 510(k) Clearance)

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

K131883 · Inovise Medical, Inc. · Anesthesiology device
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Apr 2014
Decision
290d
Days
Class 2
Risk

K131883 is an FDA 510(k) clearance for the AUDICOR CPAM WITH SDB (ACCELEROMETER BASED). 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 April 11, 2014 after a review of 290 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 K131883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date April 11, 2014
Days to Decision 290 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
151d slower than avg
Panel avg: 139d · This submission: 290d
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.