Cleared Traditional

K954803 - BLOOD GAS MIXTURES

K954803 is an FDA 510(k) clearance for BLOOD GAS MIXTURES, manufactured by Mittler Supply, Inc.. The device is a Class 1 Anesthesiology device with product code BXK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

FDA 510(k) Submission Details - K954803

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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.