Cleared Special

K003763 - 2010 PLUS HOLTER FOR WINDOWS

K003763 is an FDA 510(k) clearance for 2010 PLUS HOLTER FOR WINDOWS, manufactured by Agilent Technologies. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Special 510(k) pathway after a 30-day FDA review.

K003763 · Agilent Technologies · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
30d
Days
Class 2
Risk

K003763 is an FDA 510(k) clearance for the 2010 PLUS HOLTER FOR WINDOWS. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Agilent Technologies (Oxnard, US). The FDA issued a Cleared decision on January 5, 2001 after a review of 30 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.

FDA 510(k) Submission Details - K003763

510(k) Number K003763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date January 05, 2001
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 32
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K003763.
H-SCRIBE
K004017 · Mortara Instrument, Inc. · Jun 2001
GALIX GBI -3S-LP
K992706 · Galix Biomedical Instrumentation, Inc. · Mar 2001
2010 PLUS HOLTER FOR WINDOWS
K003940 · Agilent Technologies · Feb 2001
R.TEST EVOLUTION
K993788 · Novacor Div. · Aug 2000
MODIFICATION TO ZYMED HOLTER 2000
K992197 · Zymed Medical Instrumentation · Jul 1999
HOLTER 2000
K990170 · Zymed Medical Instrumentation · Apr 1999
K003763 · 2010 PLUS HOLTER FOR WINDOWS
Download PDF FDA Summary Agilent Technologies