Cleared Special

K112173 - SPEACELABS MULTIGAS MODULE (FDA 510(k) Clearance)

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

K112173 · Spacelabs Healthcare · Anesthesiology device
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Oct 2011
Decision
69d
Days
Class 2
Risk

K112173 is an FDA 510(k) clearance for the SPEACELABS MULTIGAS MODULE. Classified as Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (product code CBR), Class II - Special Controls.

Submitted by Spacelabs Healthcare (Nederland, US). The FDA issued a Cleared decision on October 5, 2011 after a review of 69 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K112173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2011
Decision Date October 05, 2011
Days to Decision 69 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
70d faster than avg
Panel avg: 139d · This submission: 69d
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.