Cleared Traditional

K833459 - COAXIAL VOL. VENTILATOR CIRCUIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

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

Submission Details

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
42d faster than avg
Panel avg: 139d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.