510(k) · Cleared
ClearedKing of Hearts Express + AF Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · DSH Recorder, Magnetic Tape, Medical
Cleared on Apr 5, 2002 as substantially equivalent to K920984 (Instromedix, Inc., 1992) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1992. 120 later devices descend from it.
- Decided
- Apr 5, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920984 (1992). 2 ancestors in all. 120 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK920984 King of Hearts Express (E.X.) MonitorInstromedix, Inc. · 1992
- This deviceK020825 King of Hearts Express + AF MonitorCard Guard Scientific Survival, Ltd. · 2002
- Descendant · cites it directly · 47 of its ownK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- Descendant · cites it directly · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · cites it directly · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 28 of its ownK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006 · cites it directly47descendants
- K042108Vista PlusNovacor · 2005 · cites it directly46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · cites it directly40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
- K140933Alivecor Heart MonitorAliveCor, Inc. · 2014 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920984 | King of Hearts Express (E.X.) Monitor | Instromedix, Inc. | 1992 | — |
| 0 (this device) | K020825 | King of Hearts Express + AF Monitor | Card Guard Scientific Survival, Ltd. | 2002 | — |
| +1 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| +1 | K042108 | Vista Plus | Novacor | 2005 | — |
| +1 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +2 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +2 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K920984 | King of Hearts Express (E.X.) MonitorSummary page 1…ransmitter Classification Name: Telephone Electrocardiograph Transmitter and Receiver (Per 21 CFR section 870.2920) Predicate Devices: King of Hearts® Express Monitor (K920984) and King of Hearts® Express II Monitor g(983626) [Instromedix] [21 CFR 807.92(a)(3)] The King of Hearts Express + AF Monitor is… | 1992 |
| * | K983626 | King of Hearts Express II & King of Hearts Express EZ IISummary page 1…cardiograph Transmitter and Receiver (Per 21 CFR section 870.2920) Predicate Devices: King of Hearts® Express Monitor (K920984) and King of Hearts® Express II Monitor g(983626) [Instromedix] [21 CFR 807.92(a)(3)] The King of Hearts Express + AF Monitor is equivalent to our predicate devices in that this… | 1999 |
What descends from it? (120)
See all 12011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052767 | Afibalert Atrial Fibrillation Detector | 2006 | 47 |
| K042108 | Vista Plus | 2005 | 46 |
| K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) | 2007 | 40 |
| K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor… | 2008 | 28 |
| K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac… | 2011 | 26 |
| K132649 | Reveal Linq Insertable Cardiac Monitor | 2014 | 23 |
| K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | 2007 | 17 |
| K053378 | Loop Recorder Vitaphone, 3100 Series | 2006 | 2 |
| K103706 | The Core (Cardiac Outpatient Realtime Ecg) Monitor | 2011 | 1 |
| K111745 | King of Hearts Express AF Cardiac Event Recorder | 2011 | 0 |
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?
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
This device is indicated for diagnostic evaluation of patlents who experience transient symptoms such as; Dizziness Palpitations Syncope Chest pain
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/K020825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020825: King of Hearts Express + AF Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020825
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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