Cleared Abbreviated

PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 (K031422) - FDA 510(k) Clearance

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

K031422 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
58d
Days
Class 2
Risk

K031422 is an FDA 510(k) clearance for the PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 8602.... Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 3, 2003 after a review of 58 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. 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

Submission Details

510(k) Number K031422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2003
Decision Date July 03, 2003
Days to Decision 58 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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
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