Data / Medical devices / United States / AliveCor

AliveCor: FDA-registered device maker in Mountain View, CA, United States, 19 510(k) clearances

Name: AliveCor FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

AliveCor is registered with the FDA (registration 3009715978) in Mountain View, CA, United States. It lists 7 device types. The FDA files 19 510(k) clearances under its listings, the newest dated January 9, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009715978
Address: 189 N Bernardo Avenue Suite 100, Mountain View, CA, United States, 94043
Owner or operator: AliveCor, Inc. (10041430)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 27, 2012
Registered through: 2026
Brand names listed: AliveCor ECG, AliveCor ECG for iPhone, AliveCor Heart Monitor, AliveCor Heart Monitor Universal, AliveCor Heart Monitor Universal Module, AliveCor Heart Monitor for Samsung Galaxy S4, AliveCor Heart Monitor for iPhone, AliveCor Heart Monitor for iPhone 4/4S and more

Devices it lists

Device	Product code	Class	Role	Source
Computer, Diagnostic, Programmable	DQK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Electrocardiograph Software For Over-The-Counter Use	QDA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Repackager or relabeler	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 9, 2026	K252589	Corvair Monza	MHX	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
June 7, 2024	K232035	Impala	DPS	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
June 7, 2024	K231010	Corvair	MHX	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
May 25, 2022	K220350	KardiaMobile 6L	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
April 26, 2022	K212662	AliveCor QT Service	DQK	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
March 24, 2022	K220196	Steth IO Spot	DQD	Substantially Equivalent	Stratoscientific	accessdata.fda.gov
November 30, 2021	K211668	KardiaMobile Card	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
June 30, 2021	K210753	KardiaMobile 6L	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
November 12, 2020	K201985	KardiaAI	DQK	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
January 24, 2020	K191406	KardiaMobile, KardiaStation	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
May 10, 2019	K183319	Triangle System	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
April 12, 2019	K182396	KardiaMobile, KardiaStation	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
March 11, 2019	K181823	KardiaAI	DQK	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
November 16, 2017	K171816	Kardia Band System	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
January 27, 2015	K142743	AliveCor Heart Monitor	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
December 3, 2014	K142672	AliveCor Heart Monitor	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
August 15, 2014	K140933	ALIVECOR HEART MONITOR	DXH	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
September 6, 2013	K130409	ALIVECOR HEART MONITOR	DPS	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov
November 19, 2012	K122356	ALIVECOR HEART MONITOR FOR IPHONE	DPS	Substantially Equivalent	AliveCor, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 9, 2015	70363	Class III	Terminated	Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-chan	Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.	accessdata.fda.gov

Compare with other makers

Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.