Cleared Traditional

K863711 - REGULATOR OXYGEN MECHANICAL

K863711 is an FDA 510(k) clearance for REGULATOR OXYGEN MECHANICAL, manufactured by Lifeguard Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K863711 · Lifeguard Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
126d
Days
Class 1
Risk

K863711 is an FDA 510(k) clearance for the REGULATOR OXYGEN MECHANICAL. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Lifeguard Medical Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 27, 1987 after a review of 126 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 - K863711

510(k) Number K863711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date January 27, 1987
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
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 54
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K863711.
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR
K883483 · Autoflow Products, Co. · Oct 1988
CRT PORTABLE EMERGENCY OXYGEN INHALATOR
K872170 · Cost Reduction Technologies, Inc. · Sep 1987
ACCU-FLO REGULATOR
K865077 · Alum-Ox, Inc. · Feb 1987
AIRCO PRESSURE REGULATORS
K862796 · Airco, Inc. · Aug 1986
# 10099/10225/10235/10275/10525/10625/10715/10125
K862193 · U.O. Equipment Co. · Jul 1986
PRESSURE REGULATOR
K853039 · Erie Medical · Apr 1986
K863711 · REGULATOR OXYGEN MECHANICAL
Download PDF Lifeguard Medical Pro…