510(k) · Cleared

Cleared

Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291

K031422510(k) AbbreviatedCleared Jul 3, 200358-day reviewClass II21 CFR 870.2340

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

Philips Medical Systems · DPS Electrocardiograph

Cleared on Jul 3, 2003 as substantially equivalent to K020708 (Philips Medical Systems, Inc., 2002) after a 58-day review. Its family tree reaches back 2 generations to 1990. 27 later devices descend from it.

Decided: Jul 3, 2003
Review: 58 days
Class: Class II
Product code: DPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K895520 (1990). 27 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
1 generation backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
This deviceK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
Descendant · cites it directly · 12 of its ownK050074 12-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005
Descendant · cites it directly · 11 of its ownK060167 Atria 3100, Atria 6100Cardiac Science Corporation · 2006
Descendant · 2 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
Descendant · cites it directly · 7 of its ownK072449 CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007
Descendant · cites it directly · 5 of its ownK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2005high 4 (2017) · low 0 (2008)2026

Most influential descendants

Showing 5 of 27 · See all

K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005 · cites it directly12descendants
K060167Atria 3100, Atria 6100Cardiac Science Corporation · 2006 · cites it directly11descendants
K160876PC ECGEdan Instruments, Inc. · 2017 · 2 generations on8descendants
K072449CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007 · cites it directly7descendants
K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K895520	Pagewriter Xli M1700A & Pagewriter XL M1701A	Hewlett-Packard Co.	1990	—
−1	K020708	Philips Pagewriter Touch Cardiograph, Model M5000A Series	Philips Medical Systems, Inc.	2002	2
0 (this device)	K031422	Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models…	Philips Medical Systems	2003	—
+1	K050074	12-Lead Resting Electrocardiograph, Models CP100 & CP200	Welch Allyn, Inc.	2005	—
+1	K060167	Atria 3100, Atria 6100	Cardiac Science Corporation	2006	—
+2	K160876	PC ECG	Edan Instruments, Inc.	2017	—
+1	K072449	CP100 & 200 12-Lead Resting Electrocardiographs	Welch Allyn, Inc.	2007	—
+1	K051228	Biozdx Hemodynamic Monitor and 12-Lead Ecg	Cardiodynamics International Corp.	2005	—

Descendants by year cleared

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

FIG. 1 — Lineage of K031422, 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
*	K020708	Philips Pagewriter Touch Cardiograph, Model M5000A Series	Philips Medical Systems, Inc.	2002	2

Also cleared against K020708: 5 other devices →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K050074	12-Lead Resting Electrocardiograph, Models CP100 & CP200	Welch Allyn, Inc.	2005	12
K060167	Atria 3100, Atria 6100	Cardiac Science Corporation	2006	11
K072449	CP100 & 200 12-Lead Resting Electrocardiographs	Welch Allyn, Inc.	2007	7
K051228	Biozdx Hemodynamic Monitor and 12-Lead Ecg	Cardiodynamics International Corp.	2005	5

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?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K050074 (Welch Allyn, Inc., 2005) has gone furthest, with 12 descendants of its own.
5 other devices also cite its predicate K020708.

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

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 as stated in the FDA summary.

https://510kreport.com/device/K031422 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031422: Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031422

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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