Cleared Traditional

K162811 - MR Conditional CGA 870 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K162811 · Essex Industries, Inc. · Anesthesiology device
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Mar 2017
Decision
147d
Days
Class 1
Risk

K162811 is an FDA 510(k) clearance for the MR Conditional CGA 870. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 2, 2017 after a review of 147 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 Essex Industries, Inc. devices

Submission Details

510(k) Number K162811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2016
Decision Date March 02, 2017
Days to Decision 147 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
8d slower than avg
Panel avg: 139d · This submission: 147d
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.