Cleared Special

AliveCor Heart Monitor

K142672 · AliveCor, Inc. · Cardiovascular
Dec 2014
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K142672 is an FDA 510(k) clearance for the AliveCor Heart Monitor, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 3, 2014, 75 days after receiving the submission on September 19, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K142672 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2014
Decision Date December 03, 2014
Days to Decision 75 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXH — Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2920

Similar Devices — DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 296
PreemptiveAI Clinical SDK
K250233 · Measure Labs, Inc. (Dba Preemptiveai, Inc.) · Feb 2026
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
K250258 · Heartbeam, Inc. · Dec 2025
MEMO Patch M (MPT-E08R-UNC01)
K243438 · Huinno Co., Ltd. · Dec 2025
Hexoskin Medical System (7100-00016)
K243981 · Carre Technologies, Inc. · Nov 2025
VitalSigns 1-Lead Holter (VSH101)
K243003 · VitalSigns Technology Co., Ltd. · Jun 2025
QT ECG (QTERD100)
K233521 · QT Medical, Inc. · Dec 2023