Cleared Traditional

K121009 - HEARTCHECK ECG PEN WITH GEMS HOME

K121009 is the FDA 510(k) clearance for HEARTCHECK ECG PEN WITH GEMS HOME by Cardiocomm Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K121009 · Cardiocomm Solutions, Inc. · Cardiovascular device
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May 2012
Decision
44d
Days
Class 2
Risk

K121009 is an FDA 510(k) clearance for the HEARTCHECK ECG PEN WITH GEMS HOME. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiocomm Solutions, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on May 17, 2012 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiocomm Solutions, Inc. devices

Submission Details

510(k) Number K121009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2012
Decision Date May 17, 2012
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 251
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