Cleared Traditional

K130921 - ALIVECOR HEART MONITOR OTC

K130921 is an FDA 510(k) clearance for ALIVECOR HEART MONITOR OTC, 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 309-day FDA review.

K130921 · AliveCor, Inc. · Cardiovascular device
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Feb 2014
Decision
309d
Days
Class 2
Risk

K130921 is an FDA 510(k) clearance for the ALIVECOR HEART MONITOR OTC. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by AliveCor, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 6, 2014 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K130921

510(k) Number K130921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2013
Decision Date February 06, 2014
Days to Decision 309 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
184d slower than avg
Panel avg: 125d · This submission: 309d
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
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