Cleared Traditional

K152585 - Resmon PRO FULL (FDA 510(k) Clearance)

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

K152585 · Medical Graphics Corp. · Anesthesiology device
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Jun 2016
Decision
288d
Days
Class 2
Risk

K152585 is an FDA 510(k) clearance for the Resmon PRO FULL. Classified as Impedance Measuring Device Utilizing Oscillation Techniques (product code PNV), Class II - Special Controls.

Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on June 24, 2016 after a review of 288 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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.

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Submission Details

510(k) Number K152585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2015
Decision Date June 24, 2016
Days to Decision 288 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
149d slower than avg
Panel avg: 139d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNV Impedance Measuring Device Utilizing Oscillation Techniques
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
Definition This Device Measures Respiratory Impedance.
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.