Cleared Traditional

VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED (K891771) - FDA 510(k) Clearance

Class I Anesthesiology device.

K891771 · Thermadyne Holings Corp. · Anesthesiology device
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Jun 1989
Decision
91d
Days
Class 1
Risk

K891771 is an FDA 510(k) clearance for the VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Thermadyne Holings Corp. (Denton, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 91 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 Thermadyne Holings Corp. devices

Submission Details

510(k) Number K891771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date June 23, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
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.

Regulatory Peers - CAN Regulator, Pressure, Gas Cylinder

Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K891771.
VANGUARD SERIES GAS REGULATORS
K942751 · Buckman Co., Inc. · Feb 1995
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · Puritan Bennett Corp. · Jan 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
PRESSURE REGULATOR/Y CONNECTOR
K852649 · C.R. Bard, Inc. · Aug 1985
PORTABLE OXYGEN SYSTEM
K830844 · Puritan Bennett Corp. · May 1983