510(k) · Cleared
ClearedEK-Pro Arrhythmia Detection Algorithm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 6, 2003 as substantially equivalent to K020290 (General Electric Medical Systems Information Techn, 2002) after an 11-day review. Its family tree reaches back 2 generations to 2000. 1 of the 45 devices in its family, counting itself, has a Class I recall. 42 later devices descend from it.
- Decided
- May 6, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001359 (2000). 42 later devices descend from it, 3 citing it directly. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 1 generation backK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- This deviceK031320 EK-Pro Arrhythmia Detection AlgorithmGe Medical Systems Information Technologies · 2003
- Descendant · cites it directly · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- Descendant · 2 generations on · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 2 generations on · 13 of its ownK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 3 generations on · 11 of its ownK190008 Carescape OneGE Healthcare · 2019
- Descendant · 4 generations on · 10 of its ownK200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP…GE Healthcare · 2020 · Recalled
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B403 generations on · 2014
Most influential descendants
Showing 5 of 42 · See all- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · cites it directly32descendants
- K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · 2 generations on14descendants
- K131223Carescape Monitor B650GE Healthcare Finland Oy · 2013 · 2 generations on13descendants
- K190008Carescape OneGE Healthcare · 2019 · 3 generations on11descendants
- K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare · 2020 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | 1 |
| −1 | K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2002 | 1 |
| 0 (this device) | K031320 | EK-Pro Arrhythmia Detection Algorithm | Ge Medical Systems Information Technologies | 2003 | — |
| +1 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| +2 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| +2 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
| +3 | K190008 | Carescape One | GE Healthcare | 2019 | — |
| +4 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE… | GE Healthcare | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 1 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K020290 | Dash 3000/4000 Patient Monitor | 2002 |
What descends from it? (42)
See all 423 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K102239 (GE Healthcare Finland Oy, 2010) has gone furthest, with 32 descendants of its own.
- 1 other device also cites its predicate K020290.
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.
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 EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031320: EK-Pro Arrhythmia Detection Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031320
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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