# K042601: Capnostat 5

- Pathway: 510(k) (Special)
- Applicant: Respironics Novametrix, Inc.
- Decided: Nov 19, 2004 after 56 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920379 (1992). 4 ancestors in all.
15 later devices descend from it; 8 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032971: Tidal Wave SP Model 710/715                                       and 715, Respironics Novametrix, Inc. (2004) Summary page 1.

## Most influential descendants
- K062095: Mcare 300 Vital Signs Monitor, Model 91220 (2006), 3 descendants of its own
- K073280: Beneview T Series Patient Monitors, Models T8, T6 and T5 (2008), 2 descendants of its own
- K192446: CO2 Mainstream Module (2020), 1 descendant of its own
- K110922: Patient Monitor (2011), 1 descendant of its own
- K100217: Lucon M-Series Patient Monitor, Models M20 and M30 (2010), 1 descendant of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-1261-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti

## Indications for use
The intended use of the Capnostat 5 CO 2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

Source page: https://510kreport.com/device/K042601
Methodology: https://510kreport.com/methodology