510(k) · Cleared
ClearedKing of Hearts Express II & King of Hearts Express EZ II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alaris Medical Systems, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 5, 1999 after a 113-day review. The FDA summary names its predicate without a number. 121 later devices descend from it.
- Decided
- Feb 5, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
121 later devices descend from it, 1 citing it directly.
- This deviceK983626 King of Hearts Express II & King of Hearts Express EZ IIAlaris Medical Systems, Inc. · 1999
- 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 · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · 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
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983626 | King of Hearts Express II & King of Hearts Express EZ II | Alaris Medical Systems, Inc. | 1999 | — |
| +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 | — |
| +2 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +3 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 12 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 12 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 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? (7)
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 |
|---|---|---|---|
| * | — | Instromedix King of Hearts Express 3X Named without a submission number | |
| * | — | Instromedix Prince Named without a submission number | |
| * | — | Instromedix 1200 Named without a submission number | |
| * | — | Instromedix CarryAll Named without a submission number | |
| * | — | Braemar ER720 Named without a submission number | |
| * | — | TZ Medical HeartAide Plus II Named without a submission number | |
| * | — | Card Guard CG-6500 Named without a submission number |
What descends from it? (121)
See all 1211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020825 | King of Hearts Express + AF Monitor | 2002 | 120 |
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 | — |
What is it indicated for?
The King of Hearts Express® II cardiac event recorder is a patient-activated device designed for diagnostic evaluation of transient symptoms such as dizziness, palpitations, syncope and chest pain. The recorder provides single lead or multiple lead ECG morphology, which may be used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena, and p-waves. The recorder may also provide automatic recording for detected bradycardia or tachycardia rhythms. The recorder may be used with pacemaker patients to assess pacemaker activity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983626: King of Hearts Express II & King of Hearts Express EZ II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983626
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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