Cleared Traditional

K002459 - PAGEWRITER 10/10I

K002459 is the FDA 510(k) clearance for PAGEWRITER 10/10I by Agilent Technologies, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002459 · Agilent Technologies, Inc. · Cardiovascular device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002459 is an FDA 510(k) clearance for the PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Agilent Technologies, Inc. devices

Submission Details

510(k) Number K002459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date November 08, 2000
Days to Decision 90 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K002459.
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
X-SCRIBE II
K022618 · Mortara Instrument, Inc. · Sep 2002
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · Philips Medical Systems, Inc. · Apr 2002
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc. · Nov 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc. · Aug 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
K000645 · General Electric Medical Systems Information Techn · May 2000