510(k) · Cleared
ClearedAlivecor Heart Monitor Otc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AliveCor, Inc. · DPS Electrocardiograph
Cleared on Feb 6, 2014 after a 309-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 30 later devices descend from it.
- Decided
- Feb 6, 2014
- Review
- 309 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK130921 Alivecor Heart Monitor OtcAliveCor, Inc. · 2014
- Descendant · cites it directly · 28 of its ownK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 19 of its ownK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK171816 Kardia Band SystemAliveCor, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK201456 Scan MonitorWithings SA · 2021 · Recalled
- Descendant · 4 generations on · 6 of its ownK181823 KardiaAIAliveCor, Inc. · 2019
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K140933Alivecor Heart MonitorAliveCor, Inc. · 2014 · cites it directly28descendants
- K142743AliveCor Heart MonitorAliveCor, Inc. · 2015 · 2 generations on19descendants
- K171816Kardia Band SystemAliveCor, Inc. · 2017 · 3 generations on12descendants
- K201456Scan MonitorWithings SA · 2021 · 2 generations on6descendants
- K181823KardiaAIAliveCor, Inc. · 2019 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130921 | Alivecor Heart Monitor Otc | AliveCor, Inc. | 2014 | — |
| +1 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| +2 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| +3 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| +2 | K201456 | Scan Monitor | Withings SA | 2021 | 1 |
| +4 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (30)
See all 302 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, K140933 (AliveCor, Inc., 2014) has gone furthest, with 28 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130921: Alivecor Heart Monitor Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130921
Report an extraction error
Are you the manufacturer?
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