Cleared Special

K002544 - MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

K002544 is an FDA 510(k) clearance for MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM, manufactured by Oxford Instruments. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 27-day FDA review.

K002544 · Oxford Instruments · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
27d
Days
Class 2
Risk

K002544 is an FDA 510(k) clearance for the MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Oxford Instruments (Old Woking, Surrey, GB). The FDA issued a Cleared decision on September 13, 2000 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 - K002544

510(k) Number K002544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date September 13, 2000
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 436
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K002544.
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
K001852 · Itamar Medical (C.M.) 1997 , Ltd. · Feb 2001
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING
K003492 · Cambridge Heart, Inc. · Jan 2001
CATHCOR DESKTOP
K002137 · Siemens Elema AB · Oct 2000
RESPIEVENTS, VERSION 4.2
K001369 · Non-Invasive Monitoring Systems, Inc. · Jul 2000
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
K001305 · General Electric Medical Systems Information Techn · Jun 2000
ECHOCOM, IMAGECOM, DOKUCOM
K001592 · Tomtec Imaging Systems GmbH · Jun 2000
K002544 · MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
Download PDF FDA Summary Oxford Instruments