Cleared Traditional

K010949 - 2010 PLUS HOLTER FOR WINDOWS

K010949 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 Traditional 510(k) pathway after a 183-day FDA review.

K010949 · Agilent Technologies · Cardiovascular device
Download Printable Device Report (PDF)
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Sep 2001
Decision
183d
Days
Class 2
Risk

K010949 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 September 28, 2001 after a review of 183 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K010949

510(k) Number K010949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2001
Decision Date September 28, 2001
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.