Cleared Special

K071733 - DL900 SERIES HOLTER RECORDER

K071733 is an FDA 510(k) clearance for DL900 SERIES HOLTER RECORDER, manufactured by Braemar, Inc.. 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.

K071733 · Braemar, Inc. · Cardiovascular device
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Jul 2007
Decision
28d
Days
Class 2
Risk

K071733 is an FDA 510(k) clearance for the DL900 SERIES HOLTER RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Braemar, Inc. (Eagan, US). The FDA issued a Cleared decision on July 24, 2007 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.

FDA 510(k) Submission Details - K071733

510(k) Number K071733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2007
Decision Date July 24, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 63
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K071733 · DL900 SERIES HOLTER RECORDER
Download PDF Braemar, Inc.