Cleared Traditional

K823714 - DISPOSABLE NON-REBREATHING ANES. CIRCUIT

K823714 is an FDA 510(k) clearance for DISPOSABLE NON-REBREATHING ANES. CIRCUIT, manufactured by Marquest Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K823714 · Marquest Medical Products, Inc. · Anesthesiology device
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Jan 1983
Decision
28d
Days
Class 1
Risk

K823714 is an FDA 510(k) clearance for the DISPOSABLE NON-REBREATHING ANES. CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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.

View all Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K823714

510(k) Number K823714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date January 07, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 43
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K823714.
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · Airlife, Inc. · Nov 1983
SPIROMETER ISOLATION VALVE #8890
K833088 · Boehringer Mannheim Corp. · Oct 1983
BRAIN MODULE RJ-Z10
K830475 · Instrumentation Industries, Inc. · Jun 1983
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K822379 · Marquest Medical Products, Inc. · Aug 1982
ANESTHESIA BREATHING CIRCUIT
K821087 · Life Design Systems, Inc. · May 1982
CIRCUIT, BREATHING
K811700 · Marquest Medical Products, Inc. · Jul 1981