# K080652: Mercury VCO2 Module with Capnostat 5

- Pathway: 510(k) (Special)
- Applicant: Respironics Novametrix, LLC
- Decided: Jun 20, 2008 after 105 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030886: Nico with Mars, Model 7300, Respironics Novametrix, Inc. (2003) Summary page 1.

## Most influential descendants
- K092217: Mercury VCO2 (2009), 0 descendants of its own

## Recalls of this device
- Jul 29, 2011 · Not classified · Z-3288-2011: Pressure lines maybe occluded and display incorrect tidal volumes.
- Jul 29, 2011 · Not classified · Z-3287-2011: Pressure lines maybe occluded and display incorrect tidal volumes.
- Jan 4, 2011 · Not classified · Z-2168-2011: Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the d
- Jan 4, 2011 · Not classified · Z-2167-2011: Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the d

## Indications for use
The intended use of the Mercury module with Capnostat 5 is to provide: spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.

Source page: https://510kreport.com/device/K080652
Methodology: https://510kreport.com/methodology