Cleared Traditional

K923781 - MXR-2000 FLOWMETER

K923781 is an FDA 510(k) clearance for MXR-2000 FLOWMETER, manufactured by Porter Instrument Co., Inc.. The device is a Class 1 Anesthesiology device with product code CAX cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K923781 · Porter Instrument Co., Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923781

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
177d slower than avg
Panel avg: 140d · This submission: 317d
Pathway characteristics
Predicate-based equivalence.

CAX Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated

All 13
Devices cleared under the same product code (CAX) and FDA review panel - the closest regulatory comparables to K923781.
OHMEDA - LOW FLOW FLOWMETER
K910316 · Ohmeda Medical · Apr 1991
SERIES D FLOWMETER
K872718 · Puritan Bennett Corp. · Aug 1987
SELECT FLOWMETER
K854067 · Precision Medical, Inc. · Oct 1985
PRESSURE RELIEF ADAPTOR
K850559 · Precision Medical, Inc. · Apr 1985
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE
K850560 · Precision Medical, Inc. · Apr 1985
PRESET FLOWMETER
K812419 · Timeter Instrument Corp. · Sep 1981