510(k) · Cleared
ClearedKing of Hearts
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 Apr 11, 1988 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.
- Decided
- Apr 11, 1988
- Review
- 55 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK880626 King of HeartsInstromedix, Inc. · 1988
- Descendant · cites it directly · 26 of its ownK982803 Heartlink, Model IICardiac Telecom Corp. · 1998
- Descendant · 2 generations on · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 18 of its ownK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
- Descendant · 4 generations on · 7 of its ownK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK090037 Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector…Medicalgorithmics SP Z.O.O. · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K982803Heartlink, Model IICardiac Telecom Corp. · 1998 · cites it directly26descendants
- K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · 2 generations on25descendants
- K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · 3 generations on18descendants
- K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010 · 4 generations on7descendants
- K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880626 | King of Hearts | Instromedix, Inc. | 1988 | — |
| +1 | K982803 | Heartlink, Model II | Cardiac Telecom Corp. | 1998 | — |
| +2 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| +3 | K081257 | CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2008 | 2 |
| +4 | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | Cardionet, Inc. | 2010 | — |
| +3 | K090037 | Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg | Medicalgorithmics SP Z.O.O. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 282 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, K982803 (Cardiac Telecom Corp., 1998) has gone furthest, with 26 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/K880626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880626: King of Hearts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880626
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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