Cleared Traditional

K952838 - MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (FDA 510(k) Clearance)

Class I Anesthesiology device.

K952838 · Standard Welders Supply Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
92d
Days
Class 1
Risk

K952838 is an FDA 510(k) clearance for the MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by Standard Welders Supply Co. (Memphis, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 92 days - within the typical 510(k) review window.

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: 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 Standard Welders Supply Co. devices

Submission Details

510(k) Number K952838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date September 19, 1995
Days to Decision 92 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
47d faster than avg
Panel avg: 139d · This submission: 92d
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.