Cleared Special

TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY (K010505) - FDA 510(k) Clearance

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

K010505 · Brentwood Medical Technology Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
16d
Days
Class 2
Risk

K010505 is an FDA 510(k) clearance for the TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Brentwood Medical Technology Corp. (Torrance, US). The FDA issued a Cleared decision on March 9, 2001 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Brentwood Medical Technology Corp. devices

Submission Details

510(k) Number K010505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date March 09, 2001
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 127
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K010505.
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QUINTON Q-STRESS, MODEL 000483
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K974746 · Hewlett-Packard Co. · Mar 1998