Cleared Traditional

K894850 - 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI

K894850 is an FDA 510(k) clearance for 8053 TWO STAGE TYPE A-B NITROUS OXIDE T..., 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 31-day FDA review.

K894850 · Modern Engineering Co., Inc. · Anesthesiology device
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Aug 1989
Decision
31d
Days
Class 1
Risk

K894850 is an FDA 510(k) clearance for the 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI. 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 31, 1989 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K894850

510(k) Number K894850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date August 31, 1989
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
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 K894850.
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
K900115 · Ventlab Corp. · Feb 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · Puritan Bennett Corp. · Jan 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
OXYGEN THERAPY REGULATOR
K894302 · 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
K894850 · 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
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