AliveCor, Inc. - FDA 510(k) Cleared Devices
19
Total
19
Cleared
0
Denied
AliveCor, Inc. has 19 FDA 510(k) cleared cardiovascular devices. Based in San Francisco, US.
Latest FDA clearance: Jan 2026. Active since 2012.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mdqr, LLC as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
19 devices
Cleared
Jan 09, 2026
Corvair Monza
Cardiovascular
147d
Cleared
Jun 07, 2024
Corvair
Cardiovascular
427d
Cleared
Jun 07, 2024
Impala
Cardiovascular
336d
Cleared
May 25, 2022
KardiaMobile 6L
Cardiovascular
107d
Cleared
Apr 26, 2022
AliveCor QT Service
Cardiovascular
246d
Cleared
Nov 30, 2021
KardiaMobile Card
Cardiovascular
182d
Cleared
Jun 30, 2021
KardiaMobile 6L
Cardiovascular
107d
Cleared
Nov 12, 2020
KardiaAI
Cardiovascular
118d
Cleared
Jan 24, 2020
KardiaMobile, KardiaStation
Cardiovascular
241d
Cleared
May 10, 2019
Triangle System
Cardiovascular
161d
Cleared
Apr 12, 2019
KardiaMobile, KardiaStation
Cardiovascular
220d
Cleared
Mar 11, 2019
KardiaAI
Cardiovascular
245d
Cleared
Nov 16, 2017
Kardia Band System
Cardiovascular
150d
Cleared
Jan 27, 2015
AliveCor Heart Monitor
Cardiovascular
125d
Cleared
Dec 03, 2014
AliveCor Heart Monitor
Cardiovascular
75d
Cleared
Aug 15, 2014
ALIVECOR HEART MONITOR
Cardiovascular
126d
Cleared
Feb 06, 2014
ALIVECOR HEART MONITOR OTC
Cardiovascular
309d
Cleared
Sep 06, 2013
ALIVECOR HEART MONITOR
Cardiovascular
199d
Cleared
Nov 19, 2012
ALIVECOR HEART MONITOR FOR IPHONE
Cardiovascular
108d