Cleared Traditional

K162811 - MR Conditional CGA 870

K162811 is an FDA 510(k) clearance for MR Conditional CGA 870, manufactured by Essex Industries, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K162811 · Essex Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K162811

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
7d slower than avg
Panel avg: 140d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

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

All 19
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K162811.
PORTABLE OXYGEN UNIT SCA900
K080243 · San Cheong Co. , Ltd. · Apr 2009
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
K060265 · Remcore, Inc. · Oct 2006
CYL-FIL OXYGEN SYSTEM
K061785 · Responsive Respiratory, Inc. · Sep 2006
VANGUARD SERIES GAS REGULATORS
K942751 · Buckman Co., Inc. · Feb 1995
LSPI PRESSURE REGULATOR
K936187 · Life Support Products, Inc. · Jan 1994
1500 SERIES REGULATOR
K932006 · Precision Medical, Inc. · Oct 1993