510(k) · Cleared

Cleared

Mac 5000 Ecg Analysis System

K014108510(k) SpecialCleared Jan 10, 200228-day reviewClass II21 CFR 870.1425

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

General Electric Medical Systems Information Techn · DQK Computer, Diagnostic, Programmable

Cleared on Jan 10, 2002 as substantially equivalent to K991735 (General Electric Medical Systems Information Techn, 1999) and 3 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1993. 71 later devices descend from it.

Decided: Jan 10, 2002
Review: 28 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K921669 (1993). 8 ancestors in all, the oldest K820885 (1982). 71 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 3 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
2 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
1 generation backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
This deviceK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
Descendant · cites it directly · 32 of its ownK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
Descendant · cites it directly · 31 of its ownK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
Descendant · 2 generations on · 30 of its ownK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
Descendant · 3 generations on · 21 of its ownK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
Descendant · 4 generations on · 19 of its ownK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

2003high 7 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 71 · See all

K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc. · 2009 · cites it directly32descendants
K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003 · cites it directly31descendants
K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004 · 2 generations on30descendants
K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006 · 3 generations on21descendants
K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010 · 4 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K921669	Marquette SL Series Transport Remote Acquisition	Marquette Electronics, Inc.	1993	—
−2	K964750	Eagle 4000 Patient Monitor	Marquette Electronics, Inc.	1997	—
−1	K991735	Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac…	General Electric Medical Systems Information Techn	1999	—
0 (this device)	K014108	Mac 5000 Ecg Analysis System	General Electric Medical Systems Information Techn	2002	—
+1	K091513	Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6…	Edan Instruments, Inc.	2009	1
+1	K033492	Modification to Mac 5000 Ecg Analysis System	Ge Medical Systems Information Technologies	2003	—
+2	K042177	Modification to Mac 5000 Ecg Analysis System	Ge Medical Systems Information Technologies	2004	—
+3	K060833	12SL Ecg Analysis Program	Ge Medical Systems Information Technologies	2006	—
+4	K092369	12SL Ecg Analysis Program	Ge Medical Systems Information Technologies	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1989	1	0
1994	1	0
1998	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2006	2	0
2008	2	0
2009	2	0
2010	4	0
2011	6	0
2012	3	0
2013	5	0
2014	7	0
2015	4	0
2016	5	0
2017	4	0
2018	5	0
2020	2	0
2021	1	0
2022	4	0
2023	2	0
2024	6	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K014108, 1993–2026Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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? (4)

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
*	K991735	Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8… Summary page 1 …tem, ECG Analysis 74L0S 21 CFR 870.1025 Detector and Alarm, Arthythmia 74DS! Predicate Devices: Device Description: Intended Use: Mac 5000 Rest ECG Analysis System K#991735 GE Marquette ECG Analysis Program K#002209 ACI TIP! Algorithm K#974199 MAX 1 System K#890323 The Mac 5000 ECG Analysis System i…	General Electric Medical Systems Information Techn	1999	—
*	K002209	GE Marquette Ecg Analysis Program Summary page 1 …ector and Alarm, Arthythmia 74DS! Predicate Devices: Device Description: Intended Use: Mac 5000 Rest ECG Analysis System K#991735 GE Marquette ECG Analysis Program K#002209 ACI TIP! Algorithm K#974199 MAX 1 System K#890323 The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, an…	General Electric Medical Systems Information Techn	2000	—
*	K974199	Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (Aci-Tipi) Option Summary page 1 …74DS! Predicate Devices: Device Description: Intended Use: Mac 5000 Rest ECG Analysis System K#991735 GE Marquette ECG Analysis Program K#002209 ACI TIP! Algorithm K#974199 MAX 1 System K#890323 The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from su…	Marquette Medical Systems, Inc.	1998	—
*	K890323	Max-1 (Exercise Electrocardiograph) Summary page 1 …s: Device Description: Intended Use: Mac 5000 Rest ECG Analysis System K#991735 GE Marquette ECG Analysis Program K#002209 ACI TIP! Algorithm K#974199 MAX 1 System K#890323 The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. T…	Marquette Electronics, Inc.	1989	—

Also cleared against K991735: 2 other devices →

What descends from it? (71)

See all 71

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

Number	Device	Applicant	Decided	Descendants
K091513	Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…	Edan Instruments, Inc.	2009	32
K033492	Modification to Mac 5000 Ecg Analysis System	Ge Medical Systems Information Technologies	2003	31
K102830	Electrocardiograph	Edan Instruments, Inc.	2010	9
K024283	Cardiodirect, Models 12M, 12I, 12S	Reynolds Medical, Ltd.	2003	4
K120188	Electrocardiograph	Edan Instruments, Inc.	2012	0
K111805	Ecg Series Electrocardiograph	Advanced Instrumentations, Inc.	2011	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 9 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K091513 (Edan Instruments, Inc., 2009) has gone furthest, with 32 descendants of its own.
2 other devices also cite its predicate K991735.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

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/K014108 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014108: Mac 5000 Ecg Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014108

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026