Cleared Traditional

K895956 - RX02 EMERGENCY MEDICAL OXYGEN

K895956 is the FDA 510(k) clearance for RX02 EMERGENCY MEDICAL OXYGEN by Progressive Medical Applications Corp.. It is a Class 1 Anesthesiology device (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.

View all Progressive Medical Applications Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 140d · This submission: 176d
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 K895956.
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