Cleared Traditional

K950581 - SMART ANESTHESIA MULTI-GAS (SAM) MODULE

K950581 is the FDA 510(k) clearance for SMART ANESTHESIA MULTI-GAS (SAM) MODULE by Marquette Electronics, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K950581 · Marquette Electronics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
48d
Days
Class 2
Risk

K950581 is an FDA 510(k) clearance for the SMART ANESTHESIA MULTI-GAS (SAM) MODULE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 29, 1995 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K950581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date March 29, 1995
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 147
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