Cleared Traditional

K833351 - DEMAND OXYGEN CONTROLLER

K833351 is an FDA 510(k) clearance for DEMAND OXYGEN CONTROLLER, manufactured by Healthdyne, Inc.. The device is a Class 1 Anesthesiology device with product code BZB cleared through the Traditional 510(k) pathway after a 173-day FDA review.

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

FDA 510(k) Submission Details - K833351

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 140d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

BZB Device Classification - Class 1, General Controls

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.

Regulatory Peers - BZB Catheter, Nasal, Oxygen

Devices cleared under the same product code (BZB) and FDA review panel - the closest regulatory comparables to K833351.
PHARMA-PLAST OXYGEN CATHETER
K843466 · Zimmar Consulting , Ltd. · Nov 1984
OXYGEN CATHETERS
K830984 · Medovations, Inc. · May 1983
NASAL OXYGEN CATHETER
K820370 · American Pharmaseal Div. Ahsc · Apr 1982
CONPHAR OXYGEN CATHETER-STERILE
K791273 · Conphar, Inc. · Jul 1979
CATHETER, OXYGEN
K790057 · Medline Industries, Inc. · Feb 1979