510(k) · Cleared
ClearedKardiaMobile, KardiaStation
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 Jan 24, 2020 as substantially equivalent to K182396 (AliveCor, Inc., 2019) and 1 other predicate after a 241-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Jan 24, 2020
- Review
- 241 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN180044 (2018). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN180044 ECG AppApple, Inc. · 2018
- This deviceK191406 KardiaMobile, KardiaStationAliveCor, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK211668 KardiaMobile CardAliveCor, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK202228 Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180044 | ECG App | Apple, Inc. | 2018 | — |
| 0 (this device) | K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020 | — |
| +1 | K211668 | KardiaMobile Card | AliveCor, Inc. | 2021 | — |
| +1 | K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K182396 | KardiaMobile, KardiaStationSummary page 4…Telephone electrocardiograph transmitter and receiver, Class II Product Code: DXH, DPS, QDA Establishment Registration: 3009715978 PREDICATE DEVICE(S) [807.92(a)(3)] K182396 – AliveCor KardiaMobile System (Primary predicate) DEN180044 – Apple Inc. ECG App (Secondary predicate)… | 2019 |
| * | DEN180044 | ECG AppSummary page 4…ss II Product Code: DXH, DPS, QDA Establishment Registration: 3009715978 PREDICATE DEVICE(S) [807.92(a)(3)] K182396 – AliveCor KardiaMobile System (Primary predicate) DEN180044 – Apple Inc. ECG App (Secondary predicate) Page 1 of 6 510(K) SUMM… | 2018 |
| † | K181823 | KardiaAI | 2019 |
What descends from it? (2)
2 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?
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. 2020, 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 KardiaMobile System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191406: KardiaMobile, KardiaStation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191406
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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