510(k) · Cleared
Cleared12SL Ecg Analysis Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 5, 2015 as substantially equivalent to K092369 (Ge Medical Systems Information Technologies, 2010) after a 202-day review. Its family tree reaches back 8 generations to 1993. 6 later devices descend from it.
- Decided
- Feb 5, 2015
- Review
- 202 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921669 (1993). 13 ancestors in all, the oldest K820885 (1982). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 7 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 6 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 5 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 4 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 3 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 2 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 1 generation backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- This deviceK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK231010 CorvairAliveCor, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK170155 EK12 AlgorithmGe Medical Systems Information Technologies, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK152993 MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK252589 Corvair MonzaAliveCor, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK221904 EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231010CorvairAliveCor, Inc. · 2024 · cites it directly1descendant
- K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc. · 2017 · cites it directly1descendant
- K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2016 · cites it directly1descendant
- K252589Corvair MonzaAliveCor, Inc. · 2026 · 2 generations on0descendants
- K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −7 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −6 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −5 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −4 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −3 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −2 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| −1 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| 0 (this device) | K141963 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies, Inc. | 2015 | — |
| +1 | K231010 | Corvair | AliveCor, Inc. | 2024 | — |
| +1 | K170155 | EK12 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2017 | — |
| +1 | K152993 | MUSE Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2016 | 1 |
| +2 | K252589 | Corvair Monza | AliveCor, Inc. | 2026 | — |
| +2 | K221904 | EK12 V2 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K092369 | 12SL Ecg Analysis ProgramSummary page 4…gram employs the same functional scientific technology as its predicate device.12SL ECG Analysis Program (K092369). Determination of Substantial Summary of Non-Clinical Tests: Equivalence: The… | 2010 |
What descends from it? (6)
3 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 22 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K231010 (AliveCor, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K092369.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. The interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The…
Read the full statement (106 words)
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. The interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients’ homes.
The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141963 · printed Nov 3, 2026
Cite this page
510(k) Report. “K141963: 12SL Ecg Analysis Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K141963
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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