Cleared Traditional

HEARTTRENDS (K012825) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012825 · Lev-El, Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2002
Decision
208d
Days
Class 2
Risk

K012825 is an FDA 510(k) clearance for the HEARTTRENDS. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Lev-El, Ltd. (M.P. Misgav, IL). The FDA issued a Cleared decision on March 19, 2002 after a review of 208 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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.

View all Lev-El, Ltd. devices

Submission Details

510(k) Number K012825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date March 19, 2002
Days to Decision 208 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
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 175
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