# K013624: Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors, Blood Analysis Portal System Plug-I

- Pathway: 510(k) (Special)
- Applicant: Philips Medizin Systeme Boblingen GmbH
- Decided: Dec 3, 2001 after 28 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941811 (1994). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002758: Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A, Agilent Technologies Deutschland GmbH (2001) Summary page 3.
- K001722: Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module, Agilent Technologies Deutschland GmbH (2000) Summary page 3.
- K001333: Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Noni, Agilent Technologies Deutschland GmbH (2000) Summary page 3.
- K992674: HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027A, Hewlett-Packard GmbH (1999) Summary page 3.
- K923682: Model M1032A Vuelink Interface Plug-in Module, Hewlett-Packard Co. (1992) Summary page 3.
- K981270: Irma Blood Analysis System, Diametrics Medical, Inc. (1998) Summary page 3.
- K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989) Summary page 3.
- K940918: I-Stat 200 Portable Clinical Analyzer, I-Stat Corp. (1994) Summary page 3.

## Indications for use
The Component Monitoring System and V24/V26 family of patient monitors is intended for the monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by healthcare professionals whenever there is a need for monitoring the physiologic parameters of adult, neonatal, and pediatric patients.

Source page: https://510kreport.com/device/K013624
Methodology: https://510kreport.com/methodology