Cleared Traditional

K161472 - Walk-O2-Bout

K161472 is an FDA 510(k) clearance for Walk-O2-Bout, manufactured by Essex Industries, Inc.. The device is a Class 1 Anesthesiology device with product code ECX cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K161472 · Essex Industries, Inc. · Anesthesiology device
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Nov 2016
Decision
175d
Days
Class 1
Risk

K161472 is an FDA 510(k) clearance for the Walk-O2-Bout. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 18, 2016 after a review of 175 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 Essex Industries, Inc. devices

FDA 510(k) Submission Details - K161472

510(k) Number K161472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2016
Decision Date November 18, 2016
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
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.