510(k) · Cleared
ClearedEK12 V2 Algorithm
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 Dec 20, 2022 as substantially equivalent to K170155 (Ge Medical Systems Information Technologies, Inc., 2017) after a 173-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Dec 20, 2022
- Review
- 173 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921669 (1993). 18 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations between
- 3 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 2 generations backK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- 1 generation backK170155 EK12 AlgorithmGe Medical Systems Information Technologies, Inc. · 2017
- This deviceK221904 EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 9 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 8 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 7 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 6 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 5 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 4 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 3 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 2 generations backK141963 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc. · 2015
- 1 generation backK170155 EK12 AlgorithmGe Medical Systems Information Technologies, Inc. · 2017
- This deviceK221904 EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −9 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −8 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −7 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −6 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −5 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −4 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| −3 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| −2 | K141963 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies, Inc. | 2015 | — |
| −1 | K170155 | EK12 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2017 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K170155 | EK12 AlgorithmSummary page 4…(With Arrhythmia Detection or Alarms) Product Code: MHX , 21 CFR 870.1025 Predicate Device(s): Ek12 Algorithm (K170155) Reference Device: 12SL ECG Analysis Program (K141963) Device Description: EK12 V2 algorithm is a soft… | 2017 |
| † | K141963 | 12SL Ecg Analysis Program | 2015 |
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 29 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
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. 2022, 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?
EK12 V2 analyzes 10 or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements.
EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnostic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
EK12 V2 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or physician’s office.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221904: EK12 V2 Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221904
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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