Cleared Traditional

K873586 - LUNG DIFFUSION GAS

K873586 is an FDA 510(k) clearance for LUNG DIFFUSION GAS, manufactured by National Welders. The device is a Class 1 Anesthesiology device with product code BXK cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K873586 · National Welders · Anesthesiology device
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Feb 1988
Decision
161d
Days
Class 1
Risk

K873586 is an FDA 510(k) clearance for the LUNG DIFFUSION GAS. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by National Welders (Charlotte, US). The FDA issued a Cleared decision on February 12, 1988 after a review of 161 days - an extended review 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: 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 National Welders devices

FDA 510(k) Submission Details - K873586

510(k) Number K873586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date February 12, 1988
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 140d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

BXK Device Classification - Class 1, General Controls

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.