Cleared Traditional

K833351 - DEMAND OXYGEN CONTROLLER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K833351 · Healthdyne, Inc. · Anesthesiology device
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Mar 1984
Decision
173d
Days
Class 1
Risk

K833351 is an FDA 510(k) clearance for the DEMAND OXYGEN CONTROLLER. Classified as Catheter, Nasal, Oxygen (product code BZB), Class I - General Controls.

Submitted by Healthdyne, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 173 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5350 - 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 Healthdyne, Inc. devices

Submission Details

510(k) Number K833351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1983
Decision Date March 19, 1984
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 139d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZB Catheter, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5350
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.