Cleared Traditional

K920783 - OXYGEN FLOW CONTROLLER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K920783 · Puritan Bennett Corp. · Anesthesiology device
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Sep 1992
Decision
211d
Days
Class 1
Risk

K920783 is an FDA 510(k) clearance for the OXYGEN FLOW CONTROLLER. Classified as Flowmeter, Nonback-pressure Compensated, Bourdon Gauge (product code CCN), Class I - General Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on September 18, 1992 after a review of 211 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2300 - 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 Puritan Bennett Corp. devices

Submission Details

510(k) Number K920783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date September 18, 1992
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 139d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCN Flowmeter, Nonback-pressure Compensated, Bourdon Gauge
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2300
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.