Cleared Traditional

K923781 - MXR-2000 FLOWMETER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K923781 · Porter Instrument Co., Inc. · Anesthesiology device
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Jun 1993
Decision
317d
Days
Class 1
Risk

K923781 is an FDA 510(k) clearance for the MXR-2000 FLOWMETER. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Porter Instrument Co., Inc. (Washington, D.C., US). The FDA issued a Cleared decision on June 10, 1993 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2340 - 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. Elevated predicate reliance profile. 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 Porter Instrument Co., Inc. devices

Submission Details

510(k) Number K923781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date June 10, 1993
Days to Decision 317 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
178d slower than avg
Panel avg: 139d · This submission: 317d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.