Cleared Traditional

K895956 - RX02 EMERGENCY MEDICAL OXYGEN (FDA 510(k) Clearance)

Class I Anesthesiology device.

K895956 · Progressive Medical Applications Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
37d slower than avg
Panel avg: 139d · 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.