510(k) · Cleared
ClearedMobileecg System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memtec Corp. · DPS Electrocardiograph
Cleared on Mar 24, 2011 as substantially equivalent to K974351 (Micromedical, Inc., 1998) and 4 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Mar 24, 2011
- Review
- 122 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K945626 (1995). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
- 3 generations backK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
- 2 generations backK032038 Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
- 1 generation backK052883 CardioserverDatrix · 2005 · Recalled
- This deviceK103427 Mobileecg SystemMemtec Corp. · 2011
- Descendant · cites it directly · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945626 | Quinton Model 710 Stress Electrocardiograph | Quinton, Inc. | 1995 | — |
| −3 | K964784 | Synergy Cardiology Information System (00431) | Quinton, Inc. | 1997 | — |
| −2 | K032038 | Pyramis Ecg Management System Model Numbers, 92600 and 92601 | Quinton, Inc. | 2003 | — |
| −1 | K052883 | Cardioserver | Datrix | 2005 | 1 |
| 0 (this device) | K103427 | Mobileecg System | Memtec Corp. | 2011 | — |
| +1 | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K974351 | Biolog 3000 ElectrocardiographSummary page 1…es The legally marketed predicated devices to which equivalence is being claimed is: Micromedical, Inc. Biolog 3000 K974351 Datrix, Inc. Cardio WiFi and K053083… | 1998 |
| * | K053083 | Datrix Cardio Wifi ElectrocardiographSummary page 1…Micromedical, Inc. Biolog 3000 K974351 Datrix, Inc. Cardio WiFi and K053083 CardioServer K052883 ORS Diagnostic… | 2005 |
| * | K052883 | CardioserverSummary page 1…Datrix, Inc. Cardio WiFi and K053083 CardioServer K052883 ORS Diagnostic EKGCARD SYSTEM K030535… | 2005 |
| * | K030535 | Ekgcard SystemSummary page 1…CardioServer K052883 ORS Diagnostic EKGCARD SYSTEM K030535 Cardioview 32 K(083749 3. Description of Device The Mobil… | 2003 |
| * | K083749 | CARDIOVIEW32 Review ModuleSummary page 1…ORS Diagnostic EKGCARD SYSTEM K030535 Cardioview 32 K(083749 3. Description of Device The MobileECG System is an electrocardiograph consisting of Model 950-12LR HHC module and CardioVu… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142349 | TM eCloud ECG Analysis System | 2015 | 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 16 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K142349 (Telemed Solutions, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K974351.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The MobileECG System is intended to provide an analysis of rhythm and of detailed morphology of complex cardiac complexes for the resting 12 lead EGG in all situations, whether in a hospital or primary care setting. It is adjunct to the diagnosis of all commonly recognized EGG abnormalities such as myocardial infarction (Ml), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.
The MobileEGG System is intended for use in adults and children of any age from birth upwards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103427: Mobileecg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103427
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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