510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

AliveCor

Mountain View, CA, US

AliveCor appears in FDA device records in Mountain View, CA. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to AliveCor carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Alivecor SFOenforcement report, recall

510(k) clearance history

FDA records hold 19 510(k) clearances for AliveCor between 2012 and 2026. The busiest year on record is 2014, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for AliveCor, by decision year
YearClearances
20121
20131
20143
20151
20171
20193
20202
20212
20222
20242
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252589Corvair MonzaMHXSubstantially Equivalent
K232035ImpalaDPSSubstantially Equivalent
K231010CorvairMHXSubstantially Equivalent
K220350KardiaMobile 6LDXHSubstantially Equivalent
K212662AliveCor QT ServiceDQKSubstantially Equivalent
K211668KardiaMobile CardDXHSubstantially Equivalent
K210753KardiaMobile 6LDXHSubstantially Equivalent
K201985KardiaAIDQKSubstantially Equivalent
K191406KardiaMobile, KardiaStationDXHSubstantially Equivalent
K183319Triangle SystemDXHSubstantially Equivalent
K182396KardiaMobile, KardiaStationDXHSubstantially Equivalent
K181823KardiaAIDQKSubstantially Equivalent
K171816Kardia Band SystemDXHSubstantially Equivalent
K142743AliveCor Heart MonitorDXHSubstantially Equivalent
K142672AliveCor Heart MonitorDXHSubstantially Equivalent
K140933ALIVECOR HEART MONITORDXHSubstantially Equivalent
K130921ALIVECOR HEART MONITOR OTCDPSSubstantially Equivalent
K130409ALIVECOR HEART MONITORDPSSubstantially Equivalent
K122356ALIVECOR HEART MONITOR FOR IPHONEDPSSubstantially Equivalent

Registered establishments

FDA registered establishments for AliveCor, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097159783009715978AliveCor189 N Bernardo Avenue, Mountain View, CA 94043 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1125-2015Alive 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-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.Class IIITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets AliveCor edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain