510(k) · Cleared
ClearedMAC 7 - Resting ECG Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · DPS Electrocardiograph
Cleared on Apr 30, 2021 as substantially equivalent to K173830 (Ge Medical Systems Information Technologies, Inc., 2018) after a 123-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 30, 2021
- Review
- 123 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933143 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 4 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 3 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 2 generations backK142105 Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · Recalled
- 1 generation backK173830 MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018 · Recalled
- This deviceK203786 MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK251670 MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK221321 MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −4 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −3 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −2 | K142105 | Eli 380 Electrocardiograph | Mortara Instrument, Inc. | 2014 | 3 |
| −1 | K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2018 | 4 |
| 0 (this device) | K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2021 | — |
| +1 | K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026 | — |
| +1 | K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K173830 | MAC VU360 Resting ECG Analysis SystemSummary page 5…K203786 Page 1 of 4 Product Code(s): DPS, DQK, DXH Predicate Device(s): MAC VU360 Resting ECG Analysis System (K173830) Device Description: The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K251670 (Ge Medical Systems Information Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 MAC 7 Resting ECG Analysis System is a non-invasive prescription device. * The device is indicated for use to acquire, analyze, display and print electrocardiograms. * The device is indicated for use to provide interpretation of the data for consideration by a physician. * The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. * It is not intended as a sole…
Read the full statement (130 words)
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.
* The device is indicated for use to acquire, analyze, display and print electrocardiograms.
* The device is indicated for use to provide interpretation of the data for consideration by a physician.
* The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.
* It is not intended as a sole means of diagnosis. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
* The device is indicated for use on adult and pediatric (birth through 21 years of age) populations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203786: MAC 7 - Resting ECG Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203786
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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