Cleared Traditional

K862797 - AIRCO 2000 SERIES FLOWMETERS

K862797 is an FDA 510(k) clearance for AIRCO 2000 SERIES FLOWMETERS, manufactured by Airco, Inc.. The device is a Class 1 Anesthesiology device with product code CAX cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K862797 · Airco, Inc. · Anesthesiology device
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Aug 1986
Decision
17d
Days
Class 1
Risk

K862797 is an FDA 510(k) clearance for the AIRCO 2000 SERIES FLOWMETERS. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Airco, Inc. (Virginia Beach, US). The FDA issued a Cleared decision on August 8, 1986 after a review of 17 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K862797

510(k) Number K862797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 08, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
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 14
Devices cleared under the same product code (CAX) and FDA review panel - the closest regulatory comparables to K862797.
MXR-2000 FLOWMETER
K923781 · Porter Instrument Co., Inc. · Jun 1993
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
K862797 · AIRCO 2000 SERIES FLOWMETERS
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