Cleared Traditional

K942751 - VANGUARD SERIES GAS REGULATORS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K942751 · Buckman Co., Inc. · Anesthesiology device
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Feb 1995
Decision
244d
Days
Class 1
Risk

K942751 is an FDA 510(k) clearance for the VANGUARD SERIES GAS REGULATORS. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 244 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K942751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1994
Decision Date February 09, 1995
Days to Decision 244 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
105d slower than avg
Panel avg: 139d · This submission: 244d
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.