Cleared Traditional

K111159 - HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME

K111159 is an FDA 510(k) clearance for HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME, manufactured by Cardiocomm Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K111159 · Cardiocomm Solutions, Inc. · Cardiovascular device
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Dec 2011
Decision
241d
Days
Class 2
Risk

K111159 is an FDA 510(k) clearance for the HEARTCHECK PEN HANDHELD ECG 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 December 22, 2011 after a review of 241 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 Cardiocomm Solutions, Inc. devices

FDA 510(k) Submission Details - K111159

510(k) Number K111159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2011
Decision Date December 22, 2011
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 125d · This submission: 241d
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 405
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