510(k) · Cleared

Cleared

M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit Station

K974420510(k) TraditionalCleared Feb 19, 199887-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

Hewlett-Packard Co. · DSH Recorder, Magnetic Tape, Medical

Cleared on Feb 19, 1998 as substantially equivalent to K840932 (Marquette Electronics, Inc., 1984) after an 87-day review. Its family tree reaches back 1 generation to 1984. 17 later devices descend from it.

Decided: Feb 19, 1998
Review: 87 days
Class: Class II
Product code: DSH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K840932 (1984). 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK840932 Muse-DPMarquette Electronics, Inc. · 1984
This deviceK974420 M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B…Hewlett-Packard Co. · 1998
Descendant · cites it directly · 15 of its ownK032103 Philips Tracemaster Ecg Management System, Models M5100A and M5101APhilips Medical Systems · 2003
Descendant · cites it directly · 14 of its ownK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
Descendant · 2 generations on · 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

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 17 · See all

K032103Philips Tracemaster Ecg Management System, Models M5100A and M5101APhilips Medical Systems · 2003 · cites it directly15descendants
K031970Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003 · cites it directly14descendants
K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · 2 generations on13descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840932	Muse-DP	Marquette Electronics, Inc.	1984	—
0 (this device)	K974420	M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit…	Hewlett-Packard Co.	1998	—
+1	K032103	Philips Tracemaster Ecg Management System, Models M5100A and M5101A	Philips Medical Systems	2003	—
+1	K031970	Infinity Megacare	Siemens Medical Solutions USA, Inc.	2003	—
+2	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
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 K974420, 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 18.0 · 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
*	K840932	Muse-DP Summary page 1 …ame: unknown 5. Predicate Devices The legally marketed device to which equivalence is being claimed is the Muse 5000 System manufactured by Marquette Electronics, Inc. (K840932). The design of TraceMaster is substantially equivalent in safety and performance to a subset of the Muse 5000 features, with the…	Marquette Electronics, Inc.	1984	—

Also cleared against K840932: 3 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K032103	Philips Tracemaster Ecg Management System, Models M5100A and M5101A	Philips Medical Systems	2003	15
K031970	Infinity Megacare	Siemens Medical Solutions USA, Inc.	2003	14

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?

Its one ancestor has no recall.
Of its descendants, K032103 (Philips Medical Systems, 2003) has gone furthest, with 15 descendants of its own.
3 other devices also cite its predicate K840932.

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 M1730B TraceMaster ECG System is a computer system which allows viewing,

manual editing, printing, and archiving of digitized electrocardiograph records from

Hewlett-Packard company electrocardiograph machines.

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/K974420 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974420: M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974420

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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