510(k) Report

FDA applicant

AliveCor, Inc.

Mountain View, CA19 decisions2012–20261 recall

FDA records 19 decisions for AliveCor, Inc. (Mountain View, CA) from 2012 to 2026: 19 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DPS (Electrocardiograph). Since 2016 its 510(k)s took a median of 182 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 13 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided AliveCor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2012: 12013: 12014: 32015: 12017: 12019: 32020: 22021: 22022: 22024: 22026 (partial year): 1
2012high 3 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2012high 1 (2015) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — AliveCor, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like AliveCor, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone10decisions
  • DPSElectrocardiograph4decisions
  • DQKComputer, Diagnostic, Programmable3decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 182 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 4 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142743AliveCor Heart MonitorAliveCor, Inc. · 20155cite it
  • K181823KardiaAIAliveCor, Inc. · 20193cite it
  • K140933Alivecor Heart MonitorAliveCor, Inc. · 20143cite it
  • K171816Kardia Band SystemAliveCor, Inc. · 20173cite it
  • K182396KardiaMobile, KardiaStationAliveCor, Inc. · 20192cite it
  • K191406KardiaMobile, KardiaStationAliveCor, Inc. · 20202cite it

What has FDA decided for it lately?

  • K252589Corvair MonzaAliveCor, Inc. · 2026
  • K232035ImpalaAliveCor, Inc. · 2024
  • K231010CorvairAliveCor, Inc. · 2024
  • K220350KardiaMobile 6LAliveCor, Inc. · 2022
  • K212662AliveCor QT ServiceAliveCor, Inc. · 2022
  • K211668KardiaMobile CardAliveCor, Inc. · 2021
  • K210753KardiaMobile 6LAliveCor, Inc. · 2021
  • K201985KardiaAIAliveCor, Inc. · 2020

All 19 as AliveCor, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140933Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system…Jan 9, 2015Class III