Cleared Traditional

K954803 - BLOOD GAS MIXTURES (FDA 510(k) Clearance)

Class I Anesthesiology device.

K954803 · Mittler Supply, Inc. · Anesthesiology device
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Jan 1996
Decision
98d
Days
Class 1
Risk

K954803 is an FDA 510(k) clearance for the BLOOD GAS MIXTURES. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by Mittler Supply, Inc. (South Bend, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 98 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 Mittler Supply, Inc. devices

Submission Details

510(k) Number K954803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1995
Decision Date January 25, 1996
Days to Decision 98 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
41d faster than avg
Panel avg: 139d · This submission: 98d
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.