Cleared Traditional

K954962 - SPACELABS MEDICAL MULTIGAS ANALYZER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954962 · Spacelabs, Inc. · Anesthesiology device
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May 1996
Decision
214d
Days
Class 2
Risk

K954962 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTIGAS ANALYZER. Classified as Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (product code CBR), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on May 31, 1996 after a review of 214 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1700 - 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 Spacelabs, Inc. devices

Submission Details

510(k) Number K954962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date May 31, 1996
Days to Decision 214 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
75d slower than avg
Panel avg: 139d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBR Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1700
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.