510(k) · Cleared
ClearedCardiomagic 2000 Software
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 Jul 18, 1997 after a 283-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jul 18, 1997
- Review
- 283 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK964036 Cardiomagic 2000 SoftwareInstromedix, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK982384 MercatorHarley Street Software, Ltd. · 1999
- Descendant · 2 generations on · 5 of its ownK013354 GlobalcardioCardiocomm Solutions, Inc. · 2002
- Descendant · 3 generations on · 4 of its ownK033037 Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003
- Descendant · 3 generations on · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 4 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K982384MercatorHarley Street Software, Ltd. · 1999 · cites it directly7descendants
- K013354GlobalcardioCardiocomm Solutions, Inc. · 2002 · 2 generations on5descendants
- K033037Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003 · 3 generations on4descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · 3 generations on3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964036 | Cardiomagic 2000 Software | Instromedix, Inc. | 1997 | — |
| +1 | K982384 | Mercator | Harley Street Software, Ltd. | 1999 | — |
| +2 | K013354 | Globalcardio | Cardiocomm Solutions, Inc. | 2002 | — |
| +3 | K033037 | Modification to Globalcardio | Cardiocomm Solutions, Inc. | 2003 | — |
| +3 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +4 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | — | Previous CardioMagic products Named without a submission number | |
| * | — | PaceArt CPTS Named without a submission number | |
| * | — | PaceBase Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982384 | Mercator | 1999 | 7 |
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, K982384 (Harley Street Software, Ltd., 1999) has gone furthest, with 7 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?
Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention.
In-office acquisition and display of single and/or multi-lead ECG.
Collection, storing, reporiing, transfer, and management of patient{s) health information.
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/K964036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964036: Cardiomagic 2000 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964036
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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