Cleared Special

K053599 - SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053599 · Spacelabs Medical, Inc. · Anesthesiology device
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Apr 2006
Decision
117d
Days
Class 2
Risk

K053599 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES. Classified as Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (product code CBR), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on April 19, 2006 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spacelabs Medical, Inc. devices

Submission Details

510(k) Number K053599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date April 19, 2006
Days to Decision 117 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 139d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

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.