Cleared Traditional

K112959 - CALG-STR EXERCISE ECG ANALYSIS ALGORITHM

K112959 is an FDA 510(k) clearance for CALG-STR EXERCISE ECG ANALYSIS ALGORITHM, manufactured by Philips Health Care. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K112959

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
Combination Product No
PCCP Authorized No
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.

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 395
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K112959.
ELECTROCARDIOGRAPH
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PAGEWRITER TC 20, 30, 50, 70
K113144 · Philips Medical Systems · Apr 2012
ELECTROCARDIOGRAPH
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K111159 · Cardiocomm Solutions, Inc. · Dec 2011
MOBCARDIO SYSTEM
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K103791 · Commwell , Ltd. · Oct 2011