AliveCor, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “AliveCor, Inc.” (first 2012, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 161 days. Since 2017 the median was 182 days, against 164 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 108 |
| 2013 | 1 | 199 |
| 2014 | 3 | 126 |
| 2015 | 1 | 125 |
| 2016 | 0 | — |
| 2017 | 1 | 150 |
| 2018 | 0 | — |
| 2019 | 3 | 220 |
| 2020 | 2 | 180 |
| 2021 | 2 | 144 |
| 2022 | 2 | 176 |
| 2023 | 0 | — |
| 2024 | 2 | 382 |
| 2025 | 0 | — |
| 2026 | 1 | 147 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name AliveCor, Inc. took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 10 | 10 |
| DPS | Electrocardiograph | 4 | 4 |
| DQK | Computer, Diagnostic, Programmable | 3 | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
Review panels
- Cardiovascular (19)
Most recent AliveCor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252589 | Corvair Monza | MHX | 2026-01-09 | 147 |
| K232035 | Impala | DPS | 2024-06-07 | 336 |
| K231010 | Corvair | MHX | 2024-06-07 | 427 |
| K220350 | KardiaMobile 6L | DXH | 2022-05-25 | 107 |
| K212662 | AliveCor QT Service | DQK | 2022-04-26 | 246 |
| K211668 | KardiaMobile Card | DXH | 2021-11-30 | 182 |
| K210753 | KardiaMobile 6L | DXH | 2021-06-30 | 107 |
| K201985 | KardiaAI | DQK | 2020-11-12 | 118 |
| K191406 | KardiaMobile, KardiaStation | DXH | 2020-01-24 | 241 |
| K183319 | Triangle System | DXH | 2019-05-10 | 161 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named AliveCor, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named AliveCor, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06271577: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (Recruiting, started 2024-03-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under AliveCor, Inc.?
FDA lists 19 510(k) clearances under the applicant name “AliveCor, Inc.” (first 2012, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by AliveCor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name AliveCor, Inc. is 161 days. Since 2017: 182 days, versus 164 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under AliveCor, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 10); DPS (Electrocardiograph, 4); DQK (Computer, Diagnostic, Programmable, 3).
Next steps
- See all 19 AliveCor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, AliveCor, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.