510(k) · Cleared
ClearedMars Holter Analysis Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DQK Computer, Diagnostic, Programmable
Cleared on Jul 19, 2005 as substantially equivalent to K991786 (General Electric Medical Systems Information Techn, 1999) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1994. 8 later devices descend from it.
- Decided
- Jul 19, 2005
- Review
- 88 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930806 (1994). 8 ancestors in all, the oldest K922171 (1992). 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 2 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 1 generation backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- This deviceK051026 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 7 of its ownK093141 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009
- Descendant · 2 generations on · 6 of its ownK132437 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK162023 CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 2017
- Descendant · 4 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009 · cites it directly7descendants
- K132437Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc. · 2013 · 2 generations on6descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 3 generations on2descendants
- K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 2017 · 3 generations on1descendant
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −3 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −2 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −1 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| 0 (this device) | K051026 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K093141 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2009 | — |
| +2 | K132437 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| +3 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +3 | K162023 | CardioDay V2.5 | Getemed Medizin- Und Informationstechnik AG | 2017 | — |
| +4 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K991786 | Mars Unity Workstation with Heart Rate Variability (HRV) OptionSummary page 1…on Classification Names: 21 CFR 870.1425 Programmable Diagnostic Computer Predicate Devices: K991786 GEMS-IT MARS Unity Workstation K010949 Agilent Technologies 2010 Plus Holter for Windows… | 1999 |
| * | K010949 | 2010 Plus Holter for WindowsSummary page 1…70.1425 Programmable Diagnostic Computer Predicate Devices: K991786 GEMS-IT MARS Unity Workstation K010949 Agilent Technologies 2010 Plus Holter for Windows Device Description: The MARS Holter Analysis Workstation system isa so… | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093141 | Mars Holter Analysis Workstation | 2009 | 7 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K093141 (Ge Medical Systems Information Technologies, 2009) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K991786.
How does its category compare?
All DQK devicesDQK 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 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?
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct…
Read the full statement (184 words)
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities.
Data acquired may be use for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia
- Detection of ECG events that alter prognosis in certain forms of heart disease
- Detection and analysis of pacemaker function and failure
Determination of cardiac response to lifestyle
- Evaluation of therapeutic interventions
- Investigations in epidemiology and clinical trials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051026: Mars Holter Analysis Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051026
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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