Cleared Traditional

K130409 - ALIVECOR HEART MONITOR

K130409 is an FDA 510(k) clearance for ALIVECOR HEART MONITOR, manufactured by AliveCor, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K130409 · AliveCor, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
199d
Days
Class 2
Risk

K130409 is an FDA 510(k) clearance for the ALIVECOR HEART MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 6, 2013 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all AliveCor, Inc. devices

FDA 510(k) Submission Details - K130409

510(k) Number K130409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2013
Decision Date September 06, 2013
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 280
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K130409.
SE-601 SERIES ELECTROCARDIOGRAPH
K131503 · Edan Instruments, Inc. · Feb 2014
PC ECG
K131819 · Edan Instruments, Inc. · Nov 2013
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · Philips Medical Systems · Sep 2013
CP150 ELECTROCARDIOGRAPH
K131573 · Welch Allyn, Inc. · Jul 2013
QT GUARD PLUS ANALYSIS SYSTEM
K120770 · Ge Medical Systems Information Technologies · Dec 2012
ELI 280 ELECTROCARDIOGRAPH
K122073 · Mortara Instrument, Inc. · Aug 2012