Cleared Traditional

K944998 - CALIBRATION GAS

K944998 is an FDA 510(k) clearance for CALIBRATION GAS, manufactured by Sunox, Inc.. The device is a Class 1 Anesthesiology device with product code BXK cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K944998 · Sunox, Inc. · Anesthesiology device
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Feb 1995
Decision
113d
Days
Class 1
Risk

K944998 is an FDA 510(k) clearance for the CALIBRATION GAS. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by Sunox, Inc. (Charlotte, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 113 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 Sunox, Inc. devices

FDA 510(k) Submission Details - K944998

510(k) Number K944998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date February 03, 1995
Days to Decision 113 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
27d faster than avg
Panel avg: 140d · This submission: 113d
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.