Cleared Special

K003520 - NEXAN SYSTEM, MODEL NX-300

K003520 is an FDA 510(k) clearance for NEXAN SYSTEM, manufactured by Nexan, Ltd.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Special 510(k) pathway after a 28-day FDA review.

K003520 · Nexan, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
28d
Days
Class 2
Risk

K003520 is an FDA 510(k) clearance for the NEXAN SYSTEM, MODEL NX-300. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Nexan, Ltd. (Rockville, US). The FDA issued a Cleared decision on December 13, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nexan, Ltd. devices

FDA 510(k) Submission Details - K003520

510(k) Number K003520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2000
Decision Date December 13, 2000
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 34
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K003520.
SPIDERVIEW
K032466 · Ela Medical, Inc. · Aug 2003
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470 · General Electric Medical Systems Information Techn · Nov 2002
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc. · Jun 2002
PE 501 PC-ECG MONITOR
K992584 · Nhe Corp. · Jan 2000
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643 · Nexan Telemed , Ltd. · Dec 1999
DIGITRAKPLUS HOLTER RECORDER
K993617 · Braemar Corp. · Nov 1999