Cleared Special

PHILIPS 12-LEAD ALGORITHM (K052049) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052049 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
28d
Days
Class 2
Risk

K052049 is an FDA 510(k) clearance for the PHILIPS 12-LEAD ALGORITHM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on August 26, 2005 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medical Systems devices

Submission Details

510(k) Number K052049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date August 26, 2005
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 574
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K052049.
MAC 7 Resting ECG Analysis System
K251670 · Ge Medical Systems Information Technologies, Inc. · Jan 2026
AccurECG Analysis System (v2.0)
K252361 · Accurkardia, Inc. · Dec 2025
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025
ZBPro Diagnostic
K243252 · Zbeats, Inc. · Jul 2025
Masimo W1
K243305 · Masimo Corporation · Apr 2025