510(k) · Cleared
ClearedHeartBeam AIMIGo with 12-L ECG Synthesis Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartbeam, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Dec 8, 2025 as substantially equivalent to K982090 (Paceart, Inc., 1999) after a 314-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 8, 2025
- Review
- 314 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930806 (1994). 6 ancestors in all, the oldest K872781 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 2 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 1 generation backK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
- This deviceK250258 HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −2 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −1 | K982090 | Paceart Home Trak Plus Easi Event Recorder System | Paceart, Inc. | 1999 | — |
| 0 (this device) | K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K982090 | Paceart Home Trak Plus Easi Event Recorder SystemSummary page 6…K250258 PREDICATE DEVICE(S) [807.92(a)(3)] Primary Predicate: • PaceArt Associates, L.P., HomeTrak Plus EASI Event Recorder System (K982090) Reference Devices: • HeartBeam AIMIGo™ System (K231424) DEVICE DESCRIPTION [807.92(a)(4)] The HeartBeam AIMIGo™ System ca… | 1999 |
| † | K231424 | HeartBeam AIMIGo (TM) System | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K982090.
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. 2025, this device’s year, is highlighted.
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?
HEARTBEAM AIMIGo SYSTEM: The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of…
Read the full statement (232 words)
HEARTBEAM AIMIGo SYSTEM:
The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.
HEARTBEAM 12-L ECG SYNTHESIS SOFTWARE:
The HeartBeam 12-L ECG Synthesis Software synthesizes a 12-L ECG from the HeartBeam AIMIGo 3-Leads (in three-directions) recording device, producing a visual 12-L ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-L ECG.
The synthesized 12-L ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-L ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-L ECG. The 12-L ECG Synthesis Software is intended for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250258: HeartBeam AIMIGo with 12-L ECG Synthesis Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250258
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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