Cleared Traditional

K942645 - B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (FDA 510(k) Clearance)

Class I Anesthesiology device.

K942645 · B & F Medical Products, Inc. · Anesthesiology device
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Jul 1994
Decision
54d
Days
Class 1
Risk

K942645 is an FDA 510(k) clearance for the B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG. Classified as Gauge, Gas Pressure, Cylinder/pipeline (product code BXH), Class I - General Controls.

Submitted by B & F Medical Products, Inc. (Washington, US). The FDA issued a Cleared decision on July 27, 1994 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2610 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B & F Medical Products, Inc. devices

Submission Details

510(k) Number K942645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date July 27, 1994
Days to Decision 54 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 139d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXH Gauge, Gas Pressure, Cylinder/pipeline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2610
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.