510(k) · Cleared

Cleared

Philips Tracemaster Ecg Management System, Models M5100A and M5101A

K032103510(k) SpecialCleared Jul 22, 200314-day reviewClass II21 CFR 870.2800

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

Philips Medical Systems · DSH Recorder, Magnetic Tape, Medical

Cleared on Jul 22, 2003 as substantially equivalent to K974420 (Hewlett-Packard Co., 1998) after a 14-day review. Its family tree reaches back 2 generations to 1984. 15 later devices descend from it.

Decided: Jul 22, 2003
Review: 14 days
Class: Class II
Product code: DSH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K840932 (1984). 15 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK840932 Muse-DPMarquette Electronics, Inc. · 1984
1 generation backK974420 M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B…Hewlett-Packard Co. · 1998
This deviceK032103 Philips Tracemaster Ecg Management System, Models M5100A and M5101APhilips Medical Systems · 2003
Descendant · cites it directly · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
Descendant · 2 generations on · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
Descendant · 3 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
Descendant · 4 generations on · 6 of its ownK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
Descendant · 5 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005high 2 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 15 · See all

K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · cites it directly13descendants
K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · 2 generations on8descendants
K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 3 generations on7descendants
K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014 · 4 generations on6descendants
K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K840932	Muse-DP	Marquette Electronics, Inc.	1984	—
−1	K974420	M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit…	Hewlett-Packard Co.	1998	—
0 (this device)	K032103	Philips Tracemaster Ecg Management System, Models M5100A and M5101A	Philips Medical Systems	2003	—
+1	K050858	Ascentia Heartstation Ecg Management System	Heartlab, Inc.	2005	1
+2	K061905	Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0	Medcon, Ltd.	2006	—
+3	K113515	Horizon Cardiology Ecg Management	Mckesson Israel, Ltd.	2012	2
+4	K133534	Mckesson Cardiology Ecg Mobile	Mckesson Israel, Ltd.	2014	—
+5	K151774	CARESTREAM Vue Motion	Carestream Health, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	1	0
2012	1	0
2014	1	0
2015	2	0
2016	1	0
2017	1	0
2018	2	0
2020	1	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K032103, 1984–2025Source: 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 DSH? 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 DSH device

#1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 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
*	K974420	M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit Station Summary page 1 …hospital information systems. 4. The new device is substantially equivalent to the previously cleared M1730B/M3700A TraceMaster ECG Management System cleared under K974420. Page 32…	Hewlett-Packard Co.	1998	—

Also cleared against K974420: 1 other device →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K050858	Ascentia Heartstation Ecg Management System	Heartlab, Inc.	2005	13
K071391	Philips Heartstart 12 Lead Transfer Station, Model 989803142521	Philips Medical Systems, Inc.	2007	0

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 19 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K050858 (Heartlab, Inc., 2005) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K974420.

How does its category compare?

All DSH devices

DSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSH

4in 2025

2007high 6 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSH

205in 2025

2007high 427 (2022) · low 30 (2019)2026

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

Recalls per year · DSH

No recall names DSH since 2007.

Adverse event reports per year · DSH

213in 2025

2007high 213 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	3	84	1
2010	2	—	8
2011	6	64	3
2012	2	—	1
2013	2	—	2
2014	1	—	3
2015	2	—	8
2016	2	—	6
2017	3	91	31
2018	3	269	30
2019	3	30	76
2020	4	122	91
2021	4	263	113
2022	4	427	46
2023	6	198	65
2024	2	—	88
2025	4	205	213
2026	2	—	—

What is it indicated for?

The TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized ECG records.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032103: Philips Tracemaster Ecg Management System, Models M5100A and M5101A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032103

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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