Cleared Special

K993618 - DXP1000 HOLTER RECORDER

K993618 is an FDA 510(k) clearance for DXP1000 HOLTER RECORDER, manufactured by Braemar Corp.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Special 510(k) pathway after a 29-day FDA review.

K993618 · Braemar Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
29d
Days
Class 2
Risk

K993618 is an FDA 510(k) clearance for the DXP1000 HOLTER RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Braemar Corp. (Burnsville, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 29 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 Braemar Corp. devices

FDA 510(k) Submission Details - K993618

510(k) Number K993618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1999
Decision Date November 24, 1999
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 27
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K993618.
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
TES-20
K992425 · Tes Electrical Electronic Corp. · Oct 1999
TRACER
K982617 · Heartland Medical Systems, Inc. · Apr 1999
CMS-2000
K982843 · Industrial Technology Research Institute · Nov 1998