# K101521: ST/AR ST and Arrhythmia Software Model: Release K.O - Pathway: 510(k) (Special) - Applicant: Philips Medical Systems - Decided: Jul 29, 2010 after 57 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: 14 generations back to K941811 (1994). 136 ancestors in all. 4 later devices descend from it; 4 cite it directly. 0 of 141 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K080461: Star ST and Arrhythmia Software, Release J.0, Philips Medical Systems (2008) Summary page 1. - 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. - K014261: ST/AR ST and Arrhythmia Software, Model Release E.0, Philips Medical Systems, Inc. (2002) Summary page 1. - K021251: ST/AR ST and Arrhythmia Software, Release E.I., Philips Medical Systems (2002) - K033513: Easi Ecg Algorithm, Philips Medical Systems (2004) Summary page 1. - K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II, Philips Medical Systems, Inc. (2004) Summary page 1. - K070260: Star ST and Arrhythmia Software, Release H.0, Philips Medical Systems (2007) Summary page 1. - K073376: Philips Ecg Algorithm, Philips Medical Systems (2008) Summary page 1. - K060307: 12 RL Algorithm, Ge Medical Systems Information Technologies (2006) Summary page 1. - K030738: Siemens Multiview Infinity Telemetry System, Siemens Medical Solutions USA, Inc. (2003) Summary page 1. ## Cited in the summary but kept off the family tree - K033515: Huberpro Safety Huber Infusion Set, Command Medical Products (2004). Our reading of the summary gave K033515, FDA’s number for Huberpro Safety Huber Infusion Set (Command Medical Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips EAST ECG”. Kept off the family tree. Summary page 1. ## Most influential descendants - K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own - K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own - K151812: Patient Monitors Various Models (2016), 0 descendants of its own - K150082: Panorama Patient Monitoring Network (2015), 0 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 ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's EGG 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 ST/AR arrhythmiar analysis algorithm is to monitor a neonatal, pediatric, or adult patient EGG's for heart rate and ventricular arrhythmias, and produce events/alarms for one or two EGG 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 EGG for ST segment elevation or depression and produce events/alarms for all possible EGG 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. The intended use of the STAR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms ofarrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements. EASI ECG is intended for monitoring multiple leads of EGG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor EGG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. RLS EGG is intended for monitoring multiple leads of EGG of adults. R.LS EGO is indicated for use by health care professionals whenever there is a need to monitor EGG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. Source page: https://510kreport.com/device/K101521 Methodology: https://510kreport.com/methodology