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 Jan 26, 2026 as substantially equivalent to K203786 (Ge Medical Systems Information Technologies, Inc., 2021) after a 241-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jan 26, 2026
- Review
- 241 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933143 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 5 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 4 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 3 generations backK142105 Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · Recalled
- 2 generations backK173830 MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018 · Recalled
- 1 generation backK203786 MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2021
- This deviceK251670 MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −5 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −4 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −3 | K142105 | Eli 380 Electrocardiograph | Mortara Instrument, Inc. | 2014 | 3 |
| −2 | K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2018 | 4 |
| −1 | K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2021 | — |
| 0 (this device) | K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K203786 | MAC 7 - Resting ECG Analysis SystemSummary page 6…Page 1 of 12 K251670 MAC 7 Resting ECG Analysis System 510(k) Summary Predicate Device(s): MAC 7 Resting ECG Analysis System (K203786) Reference Device: MAC VU360 Resting ECG Analysis System (K173830) and Page Writer TC30 Cardiogra… | 2021 |
| † | K173830 | MAC VU360 Resting ECG Analysis System | 2018 |
| † | K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50… | 2021 |
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 32 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K203786.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 over-read 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/K251670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251670: 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/K251670
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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