510(k) · Cleared

Cleared

Easi 12 Lead Algorithm

K020456510(k) SpecialCleared Jul 9, 2002148-day reviewClass II21 CFR 870.2350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems · DRW Adaptor, Lead Switching, Electrocardiograph

Cleared on Jul 9, 2002 after a 148-day review. The FDA summary names no predicate by number. 221 later devices descend from it.

Decided: Jul 9, 2002
Review: 148 days
Class: Class II
Product code: DRW
Recalls: None
Predicates: 0

221 later devices descend from it, 1 citing it directly.

This deviceK020456 Easi 12 Lead AlgorithmPhilips Medical Systems · 2002
Descendant · cites it directly · 220 of its ownK033513 Easi Ecg AlgorithmPhilips Medical Systems · 2004
Descendant · 2 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
Descendant · 2 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
Descendant · 3 generations on · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
Descendant · 4 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007

Showing 5 of 221 descendants. See all descendants

Descendants cleared per year

2004high 21 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 221 · See all

K033513Easi Ecg AlgorithmPhilips Medical Systems · 2004 · cites it directly220descendants
K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 2 generations on211descendants
K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 2 generations on188descendants
K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · 3 generations on176descendants
K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 4 generations on175descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K020456	Easi 12 Lead Algorithm	Philips Medical Systems	2002	—
+1	K033513	Easi Ecg Algorithm	Philips Medical Systems	2004	—
+2	K061052	The Philips Intellivue Patient Monitors, Models…	Philips Medical Systems North America, Inc.	2006	—
+2	K062283	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…	Philips Medical Systems North America, Inc.	2006	—
+3	K062392	Philips MP5 Intellivue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	2006	—
+4	K063725	MP5 Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	5	0
2007	3	0
2008	5	0
2009	5	0
2010	6	0
2011	9	0
2012	8	0
2013	10	0
2014	9	0
2015	8	0
2016	11	0
2017	10	0
2018	13	0
2019	8	0
2020	8	0
2021	13	0
2022	18	0
2023	21	0
2024	18	0
2025	20	0
2026	12	0

FIG. 1 — Lineage of K020456, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (221)

See all 221

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033513	Easi Ecg Algorithm	Philips Medical Systems	2004	220

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K033513 (Philips Medical Systems, 2004) has gone furthest, with 220 descendants of its own.

How does its category compare?

All DRW devices

DRW Adaptor, Lead Switching, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRW

FDA has decided no DRW device since 2007.

Median 510(k) review, days · DRW

Too few DRW 510(k)s in any year since 2007 to give a median.

Recalls per year · DRW

No recall names DRW since 2007.

Adverse event reports per year · DRW

1in 2017

2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code DRW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	2
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020456: Easi 12 Lead Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020456

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026