Cleared Special

K092217 - MERCURY VCO2

K092217 is an FDA 510(k) clearance for MERCURY VCO2, manufactured by Respironics Novametrix, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Special 510(k) pathway after a 30-day FDA review.

K092217 · Respironics Novametrix, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
30d
Days
Class 2
Risk

K092217 is an FDA 510(k) clearance for the MERCURY VCO2. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Respironics Novametrix, Inc. (Wallingford, US). The FDA issued a Cleared decision on August 21, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 - K092217

510(k) Number K092217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2009
Decision Date August 21, 2009
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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.

Regulatory Peers - BZK Spirometer, Monitoring (w/wo Alarm)

All 38
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K092217.
EXSPIRON
K120087 · Respiratory Motion, Inc. · Sep 2012
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K103578 · Respironics Novametrix, LLC · Jun 2011
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
K091853 · Nspire Health, Inc. · Sep 2009
PHILIPS NM3 MONITOR, MODEL 7900
K091459 · Respironics Novametrix, LLC · Jul 2009
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
K080652 · Respironics Novametrix, LLC · Jun 2008
GAS MODULE SE, MODEL 0998-00-0481-02
K062754 · Datascope Corp. · Nov 2006