510(k) · Cleared
ClearedKing of Hearts Express (E.X.) Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instromedix, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Oct 14, 1992 after a 226-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 163 later devices descend from it.
- Decided
- Oct 14, 1992
- Review
- 226 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
163 later devices descend from it, 3 citing it directly.
- This deviceK920984 King of Hearts Express (E.X.) MonitorInstromedix, Inc. · 1992
- Descendant · cites it directly · 120 of its ownK020825 King of Hearts Express + AF MonitorCard Guard Scientific Survival, Ltd. · 2002
- Descendant · 2 generations on · 47 of its ownK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- Descendant · 2 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · cites it directly · 42 of its ownK042022 E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004
- Descendant · 2 generations on · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
Showing 5 of 163 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 163 · See all- K020825King of Hearts Express + AF MonitorCard Guard Scientific Survival, Ltd. · 2002 · cites it directly120descendants
- K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006 · 2 generations on47descendants
- K042108Vista PlusNovacor · 2005 · 2 generations on46descendants
- K042022E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004 · cites it directly42descendants
- K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · 2 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920984 | King of Hearts Express (E.X.) Monitor | Instromedix, Inc. | 1992 | — |
| +1 | K020825 | King of Hearts Express + AF Monitor | Card Guard Scientific Survival, Ltd. | 2002 | — |
| +2 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| +2 | K042108 | Vista Plus | Novacor | 2005 | — |
| +1 | K042022 | E-Tac EX-1000 Electrocardiographic Event Recorder | Datrix, Inc. Dba of Jon Barron, Inc. | 2004 | — |
| +2 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 9 | 0 |
| 2015 | 12 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 12 | 0 |
| 2020 | 12 | 0 |
| 2021 | 11 | 0 |
| 2022 | 8 | 0 |
| 2023 | 16 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (163)
See all 1633 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?
- Of its descendants, K020825 (Card Guard Scientific Survival, Ltd., 2002) has gone furthest, with 120 descendants of its own.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K920984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920984: King of Hearts Express (E.X.) Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920984
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026