510(k) · Cleared
ClearedHeartcard, Model 5258
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instromedix · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jun 12, 2001 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 183 later devices descend from it.
- Decided
- Jun 12, 2001
- Review
- 75 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
183 later devices descend from it, 4 citing it directly.
- This deviceK010945 Heartcard, Model 5258Instromedix · 2001
- Descendant · cites it directly · 181 of its ownK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- Descendant · 2 generations on · 99 of its ownK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 47 of its ownK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- Descendant · 3 generations on · 44 of its ownK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- Descendant · cites it directly · 32 of its ownK071228 Fidelity 200 Cardiac Event RecorderSignalife, Inc. · 2007
Showing 5 of 183 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 183 · See all- K012223CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001 · cites it directly181descendants
- K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005 · 2 generations on99descendants
- K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006 · cites it directly47descendants
- K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006 · 3 generations on44descendants
- K071228Fidelity 200 Cardiac Event RecorderSignalife, Inc. · 2007 · cites it directly32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010945 | Heartcard, Model 5258 | Instromedix | 2001 | — |
| +1 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| +2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| +3 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +1 | K071228 | Fidelity 200 Cardiac Event Recorder | Signalife, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 14 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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? (183)
See all 1834 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, K012223 (Card Guard Scientific Survival, Ltd., 2001) has gone furthest, with 181 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/K010945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010945: Heartcard, Model 5258.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010945
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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