510(k) · Cleared
ClearedHeartBeam AIMIGo (TM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartbeam, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Dec 13, 2024 as substantially equivalent to K210753 (AliveCor, Inc., 2021) after a 576-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Dec 13, 2024
- Review
- 576 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K963725 (1997). 23 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations between
- 3 generations backK181823 KardiaAIAliveCor, Inc. · 2019
- 2 generations backK183319 Triangle SystemAliveCor, Inc. · 2019
- 1 generation backK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- This deviceK231424 HeartBeam AIMIGo (TM) SystemHeartbeam, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 9 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 8 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 7 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 6 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 5 generations backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- 4 generations backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- 3 generations backK181823 KardiaAIAliveCor, Inc. · 2019
- 2 generations backK183319 Triangle SystemAliveCor, Inc. · 2019
- 1 generation backK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- This deviceK231424 HeartBeam AIMIGo (TM) SystemHeartbeam, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −9 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −8 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −7 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −6 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −5 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| −4 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| −3 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| −2 | K183319 | Triangle System | AliveCor, Inc. | 2019 | — |
| −1 | K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021 | — |
| 0 (this device) | K231424 | HeartBeam AIMIGo (TM) System | Heartbeam, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K210753 | KardiaMobile 6LSummary page 6…MMARY K231424 PREDICATE DEVICE(S) [807.92(a)(3)] Primary Predicate: AliveCor, Inc., KardiaMobile 6L (K210753) Reference Device: VectraCor Inc., Universal Smart ECG, VectraPlex ECG (K173952) DEVICE DESCRIPTION [807.92(a)(4)] The HeartBeam… | 2021 |
| † | K173952 | Universal SmartECG | 2018 |
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 27 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K210753.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231424: HeartBeam AIMIGo (TM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231424
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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