Cleared Special

K112173 - SPEACELABS MULTIGAS MODULE

K112173 is an FDA 510(k) clearance for SPEACELABS MULTIGAS MODULE, manufactured by Spacelabs Healthcare. The device is a Class 2 Anesthesiology device with product code CBR cleared through the Special 510(k) pathway after a 69-day FDA review.

K112173 · Spacelabs Healthcare · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K112173

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 140d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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.