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AliveCor, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252589Corvair MonzaJanuary 9, 2026
K231010CorvairJune 7, 2024
K232035ImpalaJune 7, 2024
K220350KardiaMobile 6LMay 25, 2022
K212662AliveCor QT ServiceApril 26, 2022
K211668KardiaMobile CardNovember 30, 2021
K210753KardiaMobile 6LJune 30, 2021
K201985KardiaAINovember 12, 2020
K191406KardiaMobile, KardiaStationJanuary 24, 2020
K183319Triangle SystemMay 10, 2019
K182396KardiaMobile, KardiaStationApril 12, 2019
K181823KardiaAIMarch 11, 2019
K171816Kardia Band SystemNovember 16, 2017
K142743AliveCor Heart MonitorJanuary 27, 2015
K142672AliveCor Heart MonitorDecember 3, 2014
K140933ALIVECOR HEART MONITORAugust 15, 2014
K130921ALIVECOR HEART MONITOR OTCFebruary 6, 2014
K130409ALIVECOR HEART MONITORSeptember 6, 2013
K122356ALIVECOR HEART MONITOR FOR IPHONENovember 19, 2012