Cleared Special

K020456 - EASI 12 LEAD ALGORITHM

K020456 is an FDA 510(k) clearance for EASI 12 LEAD ALGORITHM, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code DRW cleared through the Special 510(k) pathway after a 148-day FDA review.

K020456 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
148d
Days
Class 2
Risk

K020456 is an FDA 510(k) clearance for the EASI 12 LEAD ALGORITHM. Classified as Adaptor, Lead Switching, Electrocardiograph (product code DRW), Class II - Special Controls.

Submitted by Philips Medical Systems (Oxnard, US). The FDA issued a Cleared decision on July 9, 2002 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2350 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020456

510(k) Number K020456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date July 09, 2002
Days to Decision 148 days
Submission Type Special
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
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

DRW Device Classification - Class 2, Special Controls

Product Code DRW Adaptor, Lead Switching, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2350
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 - DRW Adaptor, Lead Switching, Electrocardiograph

All 7
Devices cleared under the same product code (DRW) and FDA review panel - the closest regulatory comparables to K020456.
EASI ECG ALGORITHM
K033513 · Philips Medical Systems · Jan 2004
EPCOR
K930786 · Siemens Medical Solutions USA, Inc. · Sep 1994
EASI LEAD SYSTEM CABLE ASSEMBLY
K872781 · Totemite Medical Electronics · Dec 1987
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
K861981 · Vital Signs, Inc. · Aug 1986
KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR
K851627 · Eaton Medical Group · Nov 1985
PCX-100 PATIENT INPUT LEADWIRE
K851632 · Eaton Medical Group · Nov 1985
K020456 · EASI 12 LEAD ALGORITHM
Download PDF FDA Summary Philips Medical Syste…