Cleared Traditional

K894302 - OXYGEN THERAPY REGULATOR

K894302 is the FDA 510(k) clearance for OXYGEN THERAPY REGULATOR by Modern Engineering Co., Inc.. It is a Class 1 Anesthesiology device (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.

View all Modern Engineering Co., Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 140d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K894302.
VANGUARD SERIES GAS REGULATORS
K942751 · Buckman Co., Inc. · Feb 1995
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · Puritan Bennett Corp. · Jan 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
DOWNS VPAP CIRCUIT
K852333 · Vital Signs, Inc. · Oct 1985
PRESSURE REGULATOR/Y CONNECTOR
K852649 · C.R. Bard, Inc. · Aug 1985
PORTABLE OXYGEN SYSTEM
K830844 · Puritan Bennett Corp. · May 1983