# K092217: Mercury VCO2

- Pathway: 510(k) (Special)
- Applicant: Respironics Novametrix, Inc.
- Decided: Aug 21, 2009 after 30 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: 7 generations back to K962603 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080652: Mercury VCO2 Module with Capnostat 5, Respironics Novametrix, LLC (2008) Summary page 1.

## 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/K092217
Methodology: https://510kreport.com/methodology