# K033513: Easi Ecg Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jan 15, 2004 after 70 days
- Product code: DRW (Adaptor, Lead Switching, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941811 (1994). 55 ancestors in all.
220 later devices descend from it; 19 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020456: Easi 12 Lead Algorithm, Philips Medical Systems (2002) Summary page 1.
- K990476: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg Option, Hewlett-Packard GmbH (1999) Summary page 1.
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 1.

## Most influential descendants
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), 211 descendants of its own
- K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors (2006), 188 descendants of its own
- K062392: Philips MP5 Intellivue Patient Monitor (2006), 176 descendants of its own
- K063725: MP5 Intellivue Patient Monitor (2007), 175 descendants of its own
- K061610: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2006), 155 descendants of its own

## Indications for use
EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG 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, including: -Assessment of symptoms that may be related to rhythm disturbances of the heart -Patients with palpitations -The evaluation of arrhythmias in patients from neonatal to pediatric to adult age -Assessment of risk in patients with or without symptoms, of arrhythmia -Assessment of efficacy of anti-arrhythmic therapy -Assessment of pacemaker function -Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing -Assessment of ST segment analysis in adult patients

Source page: https://510kreport.com/device/K033513
Methodology: https://510kreport.com/methodology