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)
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.

View all Respironics Novametrix, LLC devices

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
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 29
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K080652.
ExSpiron 2Xi
K192595 · Respiratory Motion · Dec 2019
Gas Module 3
K180788 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2018
ExSpiron 1Xi
K173181 · Respiratory Motion, Inc. · Mar 2018
GAS MODULE SE, MODEL 0998-00-0481-02
K062754 · Datascope Corp. · Nov 2006
STARTRACK INFANT GRAPHICS MONITOR
K983274 · Nellcor Puritan Bennett, Inc. · Dec 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086 · Alexander Mfg. Co. · Aug 1997