# AliveCor, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 19 (2012–2026): 19 510(k) clearances
- Product codes: DXH (10), DPS (4), DQK (3), MHX (2)
- 510(k) review time since 2016: median 182 days, against 150 for FDA's reviews in the same codes and years (4 of 13 faster)
- Predicates its devices cite: 19 (13 its own); citations of its devices by later devices: 25 (13 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Apple, Inc.: 1 (https://510kreport.com/company/apple)
- Cardiologs Technologies: 1 (https://510kreport.com/company/cardiologs-technologies)
- Lechnologies Research, Inc.: 1 (https://510kreport.com/company/lechnologies-research)
- Cardiac Designs, LLC: 1 (https://510kreport.com/company/cardiac-designs)
- Vectracor, Inc.: 1 (https://510kreport.com/company/vectracor)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)

## Firms that cite its devices most
- Withings: 2 (https://510kreport.com/company/withings)
- Omron Healthcare, Inc.: 2 (https://510kreport.com/company/omron-healthcare)
- Samsung Strategy and Innovation Center (Ssic): 1 (https://510kreport.com/company/samsung-strategy-and-innovation-center-ssic)
- Verily Life Sciences, LLC: 1 (https://510kreport.com/company/verily-life-sciences)
- Coala Life AB: 1 (https://510kreport.com/company/coala-life)
- Heartbeam, Inc.: 1 (https://510kreport.com/company/heartbeam)
- Cardiac Insight, Inc.: 1 (https://510kreport.com/company/cardiac-insight)
- Fourth Frontier Technologies Pvt, Ltd.: 1 (https://510kreport.com/company/fourth-frontier-technologies-pvt)

## Its most-cited devices
- K142743: AliveCor Heart Monitor (2015), cited by 5
- K181823: KardiaAI (2019), cited by 3
- K140933: Alivecor Heart Monitor (2014), cited by 3
- K171816: Kardia Band System (2017), cited by 3
- K182396: KardiaMobile, KardiaStation (2019), cited by 2
- K191406: KardiaMobile, KardiaStation (2020), cited by 2

## Recent decisions
- K252589: Corvair Monza (Jan 9, 2026)
- K232035: Impala (Jun 7, 2024)
- K231010: Corvair (Jun 7, 2024)
- K220350: KardiaMobile 6L (May 25, 2022)
- K212662: AliveCor QT Service (Apr 26, 2022)
- K211668: KardiaMobile Card (Nov 30, 2021)
- K210753: KardiaMobile 6L (Jun 30, 2021)
- K201985: KardiaAI (Nov 12, 2020)

Source page: https://510kreport.com/company/alivecor