Cleared Traditional

K894302 - OXYGEN THERAPY REGULATOR

K894302 is an FDA 510(k) clearance for OXYGEN THERAPY REGULATOR, manufactured by Modern Engineering Co., Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K894302 · Modern Engineering Co., Inc. · Anesthesiology device
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Aug 1989
Decision
96d
Days
Class 1
Risk

K894302 is an FDA 510(k) clearance for the OXYGEN THERAPY REGULATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Modern Engineering Co., Inc. (St. Louis, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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.

FDA 510(k) Submission Details - K894302

510(k) Number K894302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1989
Decision Date August 07, 1989
Days to Decision 96 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
44d faster than avg
Panel avg: 140d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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 - CAN Regulator, Pressure, Gas Cylinder

All 25
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K894302.
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · Puritan Bennett Corp. · Jan 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
K894850 · Modern Engineering Co., Inc. · Aug 1989
CONCOA PRESSURE REGULATORS
K893621 · Concoa Controls Corp. of America · Jul 1989
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · Instrumentation Industries, Inc. · Jun 1989
DOWNS VPAP CIRCUIT
K852333 · Vital Signs, Inc. · Oct 1985
K894302 · OXYGEN THERAPY REGULATOR
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