Cleared Traditional

K895956 - RX02 EMERGENCY MEDICAL OXYGEN

K895956 is an FDA 510(k) clearance for RX02 EMERGENCY MEDICAL OXYGEN, manufactured by Progressive Medical Applications Corp.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K895956 · Progressive Medical Applications Corp. · Anesthesiology device
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Apr 1990
Decision
176d
Days
Class 1
Risk

K895956 is an FDA 510(k) clearance for the RX02 EMERGENCY MEDICAL OXYGEN. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Progressive Medical Applications Corp. (Allentown, US). The FDA issued a Cleared decision on April 5, 1990 after a review of 176 days - an extended review 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: 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 - K895956

510(k) Number K895956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date April 05, 1990
Days to Decision 176 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
36d slower than avg
Panel avg: 140d · This submission: 176d
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 K895956.
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · Salter Labs · Jul 1991
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · Precision Medical, Inc. · Aug 1990
AMBU OXYGEN REGULATOR
K901623 · Flotec, Inc. · Apr 1990
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
K895956 · RX02 EMERGENCY MEDICAL OXYGEN
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