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 Apr 12, 2019 after a 220-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 220 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK182396 KardiaMobile, KardiaStationAliveCor, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK191406 KardiaMobile, KardiaStationAliveCor, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK240794 Frontier X PlusFourth Frontier Technologies Pvt, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK211668 KardiaMobile CardAliveCor, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK202228 Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K191406KardiaMobile, KardiaStationAliveCor, Inc. · 2020 · cites it directly2descendants
- K240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd. · 2024 · cites it directly0descendants
- K211668KardiaMobile CardAliveCor, Inc. · 2021 · 2 generations on0descendants
- K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182396 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2019 | — |
| +1 | K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020 | — |
| +1 | K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | 2024 | — |
| +2 | K211668 | KardiaMobile Card | AliveCor, Inc. | 2021 | — |
| +2 | K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K191406 (AliveCor, Inc., 2020) has gone furthest, with 2 descendants of its own.
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. 2019, 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 | — |
https://510kreport.com/device/K182396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182396: 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/K182396
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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