Company ยท US
AliveCor, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2026 | K252589 | Corvair Monza AliveCor, Inc. | MHX |
| Jun 7, 2024 | K232035 | Impala AliveCor, Inc. | DPS |
| Jun 7, 2024 | K231010 | Corvair AliveCor, Inc. | MHX |
| May 25, 2022 | K220350 | KardiaMobile 6L AliveCor, Inc. | DXH |
| Apr 26, 2022 | K212662 | AliveCor QT Service AliveCor, Inc. | DQK |
| Nov 30, 2021 | K211668 | KardiaMobile Card AliveCor, Inc. | DXH |
| Jun 30, 2021 | K210753 | KardiaMobile 6L AliveCor, Inc. | DXH |
| Nov 12, 2020 | K201985 | KardiaAI AliveCor, Inc. | DQK |
| Jan 24, 2020 | K191406 | KardiaMobile, KardiaStation AliveCor, Inc. | DXH |
| May 10, 2019 | K183319 | Triangle System AliveCor, Inc. | DXH |
| Apr 12, 2019 | K182396 | KardiaMobile, KardiaStation AliveCor, Inc. | DXH |
| Mar 11, 2019 | K181823 | KardiaAI AliveCor, Inc. | DQK |
| Nov 16, 2017 | K171816 | Kardia Band System AliveCor, Inc. | DXH |
| Jan 27, 2015 | K142743 | AliveCor Heart Monitor AliveCor, Inc. | DXH |
| Dec 3, 2014 | K142672 | AliveCor Heart Monitor AliveCor, Inc. | DXH |
| Aug 15, 2014 | K140933 | ALIVECOR HEART MONITOR AliveCor, Inc. | DXH |
| Feb 6, 2014 | K130921 | ALIVECOR HEART MONITOR OTC AliveCor, Inc. | DPS |
| Sep 6, 2013 | K130409 | ALIVECOR HEART MONITOR AliveCor, Inc. | DPS |
| Nov 19, 2012 | K122356 | ALIVECOR HEART MONITOR FOR IPHONE AliveCor, Inc. | DPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||