510(k) · Cleared
ClearedMobcardio System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mobhealth Incorporation · DPS Electrocardiograph
Cleared on Nov 17, 2011 as substantially equivalent to K051534 (Et Medical Devices Spa, 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 17, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002074 (2000). 4 ancestors in all, the oldest K955023 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −1 | K051534 | Cardioline AR 600, AR 1200, AR 2100 | Et Medical Devices Spa | 2005 | — |
| 0 (this device) | K113234 | Mobcardio System | Mobhealth Incorporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K051534 | Cardioline AR 600, AR 1200, AR 2100Summary page 1…Kardiosis Ltd.Electrocardiography SystemK940 FT Medical Devices Spa Cardioline AR600 K05 1534 Midmark Diagnostic Group Midmark lQecg K103640 Predicate Device C… | 2005 |
| * | K103640 | Midmark IqecgSummary page 1…ne AR600 K05 1534 Midmark Diagnostic Group Midmark lQecg K103640 Predicate Device Comparison Summary: The MobCardio System has in many instances, identical or nearly identical technological cha… | 2011 |
| * | — | ARS-EKG 12K ECG System Named without a submission number | |
| * | — | Kardiosis Ltd. Electrocardiography System Named without a submission number |
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 11 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K051534.
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 MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113234: Mobcardio System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113234
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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