510(k) · Cleared
ClearedTM eCloud ECG Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemed Solutions, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 21, 2015 as substantially equivalent to K132437 (Ge Medical Systems Information Technologies, Inc., 2013) and 3 other predicates after a 395-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 21, 2015
- Review
- 395 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K930806 (1994). 30 ancestors in all, the oldest K895208 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 6 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 5 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 4 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 3 generations backK051026 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2005
- 2 generations backK093141 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009
- 1 generation backK132437 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc. · 2013
- This deviceK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −6 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −5 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −4 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −3 | K051026 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2005 | — |
| −2 | K093141 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2009 | — |
| −1 | K132437 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| 0 (this device) | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (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 | Decided |
|---|---|---|---|
| * | K132437 | Mars Holter Analysis WorkstationSummary page 5…gally marketed predicated devices to which equivalence is being claimed is: GE Healthcare. MARS Holter Analysis Workstation K132437 Agilent Technologies 2010 Plus Holter for Windows K003940 Medtronic, Inc.… | 2013 |
| * | K003940 | 2010 Plus Holter for WindowsSummary page 5…MARS Holter Analysis Workstation K132437 Agilent Technologies 2010 Plus Holter for Windows K003940 Medtronic, Inc. Paceart OptimaTM System Software K110693 Memtec Corporation… | 2001 |
| * | K110693 | Paceart Optima System SoftwareSummary page 5…2010 Plus Holter for Windows K003940 Medtronic, Inc. Paceart OptimaTM System Software K110693 Memtec Corporation MobileECG K103427… | 2011 |
| * | K103427 | Mobileecg SystemSummary page 5…Paceart OptimaTM System Software K110693 Memtec Corporation MobileECG K103427 PAGE 1 of 5 K142349… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 2 other devices also cite its predicate K132437.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The TM eCloud ECG Analysis System, using proprietary algorithm, is intended for use in adults and children of any age from birth upwards. The Program makes significant use of the patient’s age and gender and will provide a unique diagnosis if age differs only by a few days in the case of neonates. It is a program that is based on normal limits derived using the algorithm itself with this applying to criteria for subjects of all ages, including neonates.…
Read the full statement (334 words)
The TM eCloud ECG Analysis System, using proprietary algorithm, is intended for use in adults and children of any age from birth upwards. The Program makes significant use of the patient’s age and gender and will provide a unique diagnosis if age differs only by a few days in the case of neonates. It is a program that is based on normal limits derived using the algorithm itself with this applying to criteria for subjects of all ages, including neonates.
TM eCloud ECG Analysis System is qualified to evaluate, detect, and aid in the physician diagnosis of the following cardiac arrhythmias and/or conduction defects:
• 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 indirect pacemaker function and failure
• Determination of cardiac response to lifestyle
• Evaluation of therapeutic interventions
• Investigations in epidemiology and clinical trials
• Evaluation of heart rate variability in the assessment of heart disease
TM eCloud ECG Analysis System is intended to provide an interpretation of up to 12-channel ECG in all situations including resting and ambulatory ECG including Holter, cardiac event, and mobile cardiac telemetry. This software qualifies to be used in hospitals, physician offices, and scanning services. It is designed for acquisition, analysis, edit, review, report and storage of all ECG and multi-parameter data. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), acute MI, ventricular hypertrophy, abnormal ST-T changes, lethal arrhythmias, and common rhythm abnormalities.
TM eCloud ECG Analysis System can analyze recordings performed on newborns, children, and adults.
TM eCloud ECG Analysis System’s interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG that may be detected. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142349: TM eCloud 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/K142349
Report an extraction error
Are you the manufacturer?
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