# K020456: Easi 12 Lead Algorithm

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jul 9, 2002 after 148 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
No predicates in its family tree.
221 later devices descend from it; 1 cites it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033513: Easi Ecg Algorithm (2004), 220 descendants of its own
- 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

## Indications for use
Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.

Source page: https://510kreport.com/device/K020456
Methodology: https://510kreport.com/methodology