# K014261: ST/AR ST and Arrhythmia Software, Model Release E.0

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Feb 12, 2002 after 47 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: 2 generations back to K964122 (1997). 6 ancestors in all.
263 later devices descend from it; 4 cite it directly.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964122: HP Star ST and Arrhhythmia Software, Hewlett-Packard Co. (1997) Summary page 1.
- K991773: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable P, Hewlett-Packard GmbH (1999) Summary page 1.
- K001348: ST/AR ST and Arrhythmia Software, Agilent Technologies, Inc. (2000) Summary page 1.
- K003621: ST/AR ST and Arrhythmia Software, Model Release D.0, Agilent Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K021251: ST/AR ST and Arrhythmia Software, Release E.I. (2002), 262 descendants of its own
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II (2004), 260 descendants of its own
- K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors (2004), 252 descendants of its own
- K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors (2004), 251 descendants of its own
- K050141: The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors (2005), 250 descendants of its own

## Indications for use
Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. The intended use of the STAR cardiotach is to monitor a neonatal, pediatric, or adult patient’s ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients. The intended use of the STAR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG’s for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient’s ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients. Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.

Source page: https://510kreport.com/device/K014261
Methodology: https://510kreport.com/methodology