Cleared Traditional

K954962 - SPACELABS MEDICAL MULTIGAS ANALYZER

K954962 is an FDA 510(k) clearance for SPACELABS MEDICAL MULTIGAS ANALYZER, manufactured by Spacelabs, Inc.. The device is a Class 2 Anesthesiology device with product code CBR cleared through the Traditional 510(k) pathway after a 214-day FDA review.

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

FDA 510(k) Submission Details - K954962

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 140d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBR Device Classification - Class 2, Special Controls

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.