# K172904: IntelliVue Capnography Extension, IntelliVue Microstream Extension

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Dec 26, 2017 after 95 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K941811 (1994). 195 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 4.
- K113441: Physiological Monitor, Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 4.

## Cited in the summary but kept off the family tree
- K993383: HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.B, Hewlett-Packard GmbH (2000). Our reading of the summary gave K993383, FDA’s number for HP Viridia Multi-Measurement Server/Compact Portable… (Hewlett-Packard GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Microstream Extension M3015B”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K181314: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (2018), 6 descendants of its own
- K182979: IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 (2019), 5 descendants of its own
- K223574: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) (2023), 2 descendants of its own
- K230604: IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) (2023), 1 descendant of its own
- K252726: IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) (2026), 0 descendants of its own

## Indications for use
The measurement extension adds physiological measurements (Mainstream / Sidestream CO2 and optionally temperature, invasive blood pressure, cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device. The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature and invasive blood pressure) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

Source page: https://510kreport.com/device/K172904
Methodology: https://510kreport.com/methodology
