510(k) · Cleared
Recalled · Class III · 2015Alivecor Heart Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AliveCor, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Aug 15, 2014 as substantially equivalent to K130921 (AliveCor, Inc., 2014) and 2 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1997. 28 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- DXH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K963725 (1997). 11 ancestors in all, the oldest K920984 (1992). 28 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 2 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 1 generation backK122184 Ecg CheckCardiac Designs, LLC · 2013
- This deviceK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014
- Descendant · cites it directly · 19 of its ownK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- Descendant · 2 generations on · 12 of its ownK171816 Kardia Band SystemAliveCor, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK201456 Scan MonitorWithings SA · 2021 · Recalled
- Descendant · 3 generations on · 6 of its ownK181823 KardiaAIAliveCor, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK142672 AliveCor Heart MonitorAliveCor, Inc. · 2014
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K142743AliveCor Heart MonitorAliveCor, Inc. · 2015 · cites it directly19descendants
- K171816Kardia Band SystemAliveCor, Inc. · 2017 · 2 generations on12descendants
- K201456Scan MonitorWithings SA · 2021 · cites it directly6descendants
- K181823KardiaAIAliveCor, Inc. · 2019 · 3 generations on6descendants
- K142672AliveCor Heart MonitorAliveCor, Inc. · 2014 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −1 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| 0 (this device) | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | — |
| +1 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| +2 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| +1 | K201456 | Scan Monitor | Withings SA | 2021 | 1 |
| +3 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| +1 | K142672 | AliveCor Heart Monitor | AliveCor, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K130921 | Alivecor Heart Monitor OtcSummary page 4…Heart Monitor Generic/Common Name: Electrocardiograph Classification: 21 CFR§870.2340, Electrocardiograph, Class II Product Code: DPS, DXH PREDICATE DEVICE(S) K130921 – AliveCor Heart Monitor K052767 – AfibAlert K122184 – ECG Check 30 Maiden Lane, 6th Floor | Sa… | 2014 |
| * | K052767 | Afibalert Atrial Fibrillation DetectorSummary page 4…trocardiograph Classification: 21 CFR§870.2340, Electrocardiograph, Class II Product Code: DPS, DXH PREDICATE DEVICE(S) K130921 – AliveCor Heart Monitor K052767 – AfibAlert K122184 – ECG Check 30 Maiden Lane, 6th Floor | San Francisco, CA 94108 │ 415.795.9804 | w… | 2006 |
| * | K122184 | Ecg CheckSummary page 4…ion: 21 CFR§870.2340, Electrocardiograph, Class II Product Code: DPS, DXH PREDICATE DEVICE(S) K130921 – AliveCor Heart Monitor K052767 – AfibAlert K122184 – ECG Check 30 Maiden Lane, 6th Floor | San Francisco, CA 94108 │ 415.795.9804 | www.alivecor.com 1 of 2 =… | 2013 |
What descends from it? (28)
See all 283 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2015 | Class III | Z-1125-2015 | Software change control | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K142743 (AliveCor, Inc., 2015) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K130921.
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. 2014, 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?
The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140933: Alivecor Heart Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140933
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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