Cleared Special

PREMIER 11 HOLTER (K062088) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062088 · Diagnostic Monitoring Software · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
32d
Days
Class 2
Risk

K062088 is an FDA 510(k) clearance for the PREMIER 11 HOLTER. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Diagnostic Monitoring Software (Stateline, US). The FDA issued a Cleared decision on August 25, 2006 after a review of 32 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 Diagnostic Monitoring Software devices

Submission Details

510(k) Number K062088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date August 25, 2006
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 31
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K062088.
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