Cleared Special

ComPAS2 (Computerized Pulmonary Analysis System) (K190568) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K190568 · Morgan Scientific, Inc. · Anesthesiology device
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Jun 2019
Decision
92d
Days
Class 2
Risk

K190568 is an FDA 510(k) clearance for the ComPAS2 (Computerized Pulmonary Analysis System). Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Morgan Scientific, Inc. (Haverhill, US). The FDA issued a Cleared decision on June 6, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Morgan Scientific, Inc. devices

Submission Details

510(k) Number K190568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2019
Decision Date June 06, 2019
Days to Decision 92 days
Submission Type Special
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
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 28
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