Cleared Traditional

K112959 - CALG-STR EXERCISE ECG ANALYSIS ALGORITHM

K112959 is the FDA 510(k) clearance for CALG-STR EXERCISE ECG ANALYSIS ALGORITHM by Philips Health Care. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K112959 · Philips Health Care · Cardiovascular device
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Jan 2012
Decision
114d
Days
Class 2
Risk

K112959 is an FDA 510(k) clearance for the CALG-STR EXERCISE ECG ANALYSIS ALGORITHM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Philips Health Care (Thousand Oaks, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 114 days - within the typical 510(k) review window.

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 Philips Health Care devices

Submission Details

510(k) Number K112959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date January 26, 2012
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
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 247
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RSCRIBE ELECTROCARDIOGRAPH
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