# K110474: Philips Intellivue TCG10

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decided: Sep 30, 2011 after 224 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- 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: 30 generations back to K941811 (1994). 192 ancestors in all.
84 later devices descend from it; 8 cite it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B, Philips Medical Systems, Inc. (2001) Summary page 2.
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 2.
- K040304: Philips Intellivue Patient Monitor, Models MP40 & MP50, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 2.
- K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 2.
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90, Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 2.
- K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2.
- K062392: Philips MP5 Intellivue Patient Monitor, Philips Medizin Systeme Boeblingen GmbH (2006) Summary page 2.
- K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 2.
- K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2008) Summary page 2.
- K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 2.
- K091927: Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 2.
- K100939: Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2.
- K101449: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2.
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800, Philips Medizin Systeme Boblingen GmbH (2010) Summary page 2.
- K082583: Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009). Our OCR of the scanned summary read K082483, FDA’s number for Quantra (Hologic, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Philips IntelliBridge EC10 and EC5 ID modules”.
- K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System, Radiometer Medical Aps (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90  Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K113441: Physiological Monitor, Patient Monitor (2012), 78 descendants of its own
- K120366: Intellivue Patient Monitor (2012), 46 descendants of its own
- K122439: Intellivue Patient Monitor (2012), 41 descendants of its own
- K131872: Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 (2013), 37 descendants of its own
- K130849: Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 (2013), 37 descendants of its own

## Recalls of this device
- Nov 19, 2014 · Class II · Z-0997-2015: Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients 

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

Source page: https://510kreport.com/device/K110474
Methodology: https://510kreport.com/methodology