510(k) · Cleared

Recalled · 2007

Philips Pagewriter Touch Cardiograph, Model M5000A Series

K020708510(k) AbbreviatedCleared Apr 25, 200251-day reviewClass II21 CFR 870.2340Recalls 2

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

Philips Medical Systems, Inc. · DPS Electrocardiograph

Cleared on Apr 25, 2002 as substantially equivalent to K895520 (Hewlett-Packard Co., 1990) after a 51-day review. Its family tree reaches back 1 generation to 1990. 47 later devices descend from it. It has been recalled 2 times.

Decided: Apr 25, 2002
Review: 51 days
Class: Class II
Product code: DPS
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K895520 (1990). 47 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
This deviceK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002
Descendant · cites it directly · 27 of its ownK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
Descendant · 2 generations on · 12 of its ownK050074 12-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005
Descendant · 2 generations on · 11 of its ownK060167 Atria 3100, Atria 6100Cardiac Science Corporation · 2006
Descendant · 3 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
Descendant · cites it directly · 7 of its ownK080999 Pagewriter CardiographPhilips Medical Systems · 2008

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2003high 5 (2022) · low 0 (2004)2026

Most influential descendants

Showing 5 of 47 · See all

K031422Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Philips Medical Systems · 2003 · cites it directly27descendants
K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005 · 2 generations on12descendants
K060167Atria 3100, Atria 6100Cardiac Science Corporation · 2006 · 2 generations on11descendants
K160876PC ECGEdan Instruments, Inc. · 2017 · 3 generations on8descendants
K080999Pagewriter CardiographPhilips Medical Systems · 2008 · cites it directly7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895520	Pagewriter Xli M1700A & Pagewriter XL M1701A	Hewlett-Packard Co.	1990	—
0 (this device)	K020708	Philips Pagewriter Touch Cardiograph, Model M5000A Series	Philips Medical Systems, Inc.	2002	—
+1	K031422	Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models…	Philips Medical Systems	2003	—
+2	K050074	12-Lead Resting Electrocardiograph, Models CP100 & CP200	Welch Allyn, Inc.	2005	—
+2	K060167	Atria 3100, Atria 6100	Cardiac Science Corporation	2006	—
+3	K160876	PC ECG	Edan Instruments, Inc.	2017	—
+1	K080999	Pagewriter Cardiograph	Philips Medical Systems	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	3	0
2006	1	0
2007	2	0
2008	2	0
2009	2	0
2010	2	0
2011	2	0
2012	2	0
2013	3	0
2014	1	0
2015	3	0
2016	3	0
2017	4	0
2018	1	0
2020	1	0
2021	3	0
2022	5	0
2023	3	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K020708, 1990–2026Source: 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 DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DPS device

#1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K895520	Pagewriter Xli M1700A & Pagewriter XL M1701A Summary page 1 …s to which equivalence is being claimed is the M1700A Cardiograph manufactured by Philips Medical ‘Systems (formerly Healthcare Solutions Group of Hewlett-Packard Co.) — K895520 6. DEVICE DESCRIPTION The M5000A Series Cardiograph is Philips Medical Systems’ cardiograph offering a full complement of featu…	Hewlett-Packard Co.	1990	—

Also cleared against K895520: 3 other devices →

What descends from it? (47)

See all 47

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031422	Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…	Philips Medical Systems	2003	27
K080999	Pagewriter Cardiograph	Philips Medical Systems	2008	7
K052049	Philips 12-Lead Algorithm	Philips Medical Systems	2005	7
K073376	Philips Ecg Algorithm	Philips Medical Systems	2008	5
K123130	Answatch Wrist Monitor Model TS-0411	Taiwan Scientific Corporation	2013	2
K132068	Philips DXL 12/16-Lead Ecg Algorithm	Philips Medical Systems	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 12, 2007	Not classified	Z-0124-2008	Software change control	Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.
Oct 13, 2004	Not classified	Z-0063-05	Other	Software can generate printed ECG's that associate incorrect patient data with the waveform

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K031422 (Philips Medical Systems, 2003) has gone furthest, with 27 descendants of its own.
3 other devices also cite its predicate K895520.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007high 121 (2011) · low 9 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	87	2	9
2008	13	31	0	17
2009	14	84	1	14
2010	11	104	2	21
2011	22	154	1	121
2012	12	117	0	56
2013	10	134	0	15
2014	11	253	0	15
2015	8	178	0	30
2016	11	229	0	12
2017	9	177	0	15
2018	14	221	0	19
2019	3	178	9	27
2020	6	224	2	59
2021	5	135	1	24
2022	6	244	1	59
2023	10	236	3	54
2024	8	260	4 (1)	64
2025	6	163	3	55
2026	6	258	4	—

What is it indicated for?

Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020708: Philips Pagewriter Touch Cardiograph, Model M5000A Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020708

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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