Cleared Traditional

K062300 - OX-SOX

K062300 is an FDA 510(k) clearance for OX-SOX, manufactured by Pattient Safety Innovations, Llp. The device is a Class 1 Anesthesiology device with product code ECX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K062300 · Pattient Safety Innovations, Llp · Anesthesiology device
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Nov 2006
Decision
111d
Days
Class 1
Risk

K062300 is an FDA 510(k) clearance for the OX-SOX, MODEL C, D, E,. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Pattient Safety Innovations, Llp (Howell, US). The FDA issued a Cleared decision on November 27, 2006 after a review of 111 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 Pattient Safety Innovations, Llp devices

FDA 510(k) Submission Details - K062300

510(k) Number K062300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2006
Decision Date November 27, 2006
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 140d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

ECX Device Classification - Class 1, General Controls

Product Code ECX Cylinder, Compressed Gas, And Valve
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.