Cleared Traditional

K833459 - COAXIAL VOL. VENTILATOR CIRCUIT

K833459 is an FDA 510(k) clearance for COAXIAL VOL. VENTILATOR CIRCUIT, manufactured by Airco/Ohio Medical Products. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K833459 · Airco/Ohio Medical Products · Anesthesiology device
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Jan 1984
Decision
97d
Days
Class 1
Risk

K833459 is an FDA 510(k) clearance for the COAXIAL VOL. VENTILATOR CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Airco/Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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. Standard predicate reliance. 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 Airco/Ohio Medical Products devices

FDA 510(k) Submission Details - K833459

510(k) Number K833459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date January 10, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 140d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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 - BZO Set, Tubing And Support, Ventilator (w Harness)

All 53
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K833459.
MASS SPECTROMETER INTERFACE
K841722 · Dryden Corp. · May 1984
THREE PORT SENSOR MANIFOLD
K841637 · Dryden Corp. · May 1984
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
K834570 · Airlife, Inc. · Mar 1984
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · Hudson Oxygen Therapy Sales Co. · Sep 1983
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
K823271 · Intec Medical, Inc. · Dec 1982
BE #16 - MANIFOLD
K823481 · Instrumentation Industries, Inc. · Dec 1982