Cleared Traditional

K953934 - MED-TECH LUNG DIFFUSION MIXTURE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K953934 · Medical Technical Gases Inc.. · Anesthesiology device
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Sep 1995
Decision
31d
Days
Class 1
Risk

K953934 is an FDA 510(k) clearance for the MED-TECH LUNG DIFFUSION MIXTURE. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by Medical Technical Gases Inc.. (Medford, US). The FDA issued a Cleared decision on September 18, 1995 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6400 - 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 Medical Technical Gases Inc.. devices

Submission Details

510(k) Number K953934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1995
Decision Date September 18, 1995
Days to Decision 31 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
108d faster than avg
Panel avg: 139d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXK Gas, Calibration (specified Concentration)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6400
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.