Cleared Special

K080652 - MERCURY VCO2 MODULE WITH CAPNOSTAT 5

K080652 is an FDA 510(k) clearance for MERCURY VCO2 MODULE WITH CAPNOSTAT 5, manufactured by Respironics Novametrix, LLC. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Special 510(k) pathway after a 105-day FDA review.

K080652 · Respironics Novametrix, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
105d
Days
Class 2
Risk

K080652 is an FDA 510(k) clearance for the MERCURY VCO2 MODULE WITH CAPNOSTAT 5. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Respironics Novametrix, LLC (Wallingford, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 105 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K080652

510(k) Number K080652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2008
Decision Date June 20, 2008
Days to Decision 105 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
35d faster than avg
Panel avg: 140d · This submission: 105d
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 K080652.
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
K091853 · Nspire Health, Inc. · Sep 2009
MERCURY VCO2
K092217 · Respironics Novametrix, Inc. · Aug 2009
PHILIPS NM3 MONITOR, MODEL 7900
K091459 · Respironics Novametrix, LLC · Jul 2009
GAS MODULE SE, MODEL 0998-00-0481-02
K062754 · Datascope Corp. · Nov 2006
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
K051279 · Caldyne, Inc. · Sep 2005
STARTRACK INFANT GRAPHICS MONITOR
K983274 · Nellcor Puritan Bennett, Inc. · Dec 1998