Cleared Abbreviated

K031422 - PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291

K031422 is an FDA 510(k) clearance for PHILIPS PAGE WRITER TRIM SERIES CARDIOG..., manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K031422 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K031422

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Entela, Inc.
NED E DEVINE

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 - DPS Electrocardiograph

All 577
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K031422.
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · Remco Italia S.P.A. · Oct 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · Reynolds Medical , Ltd. · Aug 2003
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc. · Jul 2003
PRIME ECG SYSTEM
K030104 · Meridian Medical Technologies, Inc. · Jun 2003
EKGCARD SYSTEM
K030535 · Qrs Diagnostic, LLC · Jun 2003
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
K031422 · PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
Download PDF FDA Summary Philips Medical Syste…