Cleared Abbreviated

K110287 - PHILIPS ECG LEADWIRE SET

K110287 is an FDA 510(k) clearance for PHILIPS ECG LEADWIRE SET, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

K110287 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
15d
Days
Class 2
Risk

K110287 is an FDA 510(k) clearance for the PHILIPS ECG LEADWIRE SET. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on February 15, 2011 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems devices

FDA 510(k) Submission Details - K110287

510(k) Number K110287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date February 15, 2011
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 Consultant

Tuv Sud America, Inc.
DAWN TIBODEAU

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 66
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K110287.
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K093657 · Acist Medical Systems, Inc. · Jan 2010
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K082851 · Ge Medical Systems Information Technologies · Nov 2008
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K082959 · Unimed Medical Supplies, Inc. · Oct 2008