Cleared Traditional

K920783 - OXYGEN FLOW CONTROLLER

K920783 is an FDA 510(k) clearance for OXYGEN FLOW CONTROLLER, manufactured by Puritan Bennett Corp.. The device is a Class 1 Anesthesiology device with product code CCN cleared through the Traditional 510(k) pathway after a 211-day FDA review.

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

FDA 510(k) Submission Details - K920783

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

CCN Device Classification - Class 1, General Controls

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.