Not Cleared Traditional

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (K792441) - FDA 510(k) Clearance

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

K792441 · Edwards Laboratories · Cardiovascular device
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Mar 1980
Decision
109d
Days
Class 2
Risk

K792441 is an FDA 510(k) submission (not cleared) for the CARPENTIER-EDWARDS FLEX. ANNULOPLASTY. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Edwards Laboratories (Mchenry, US). The FDA issued a Not Cleared (DENG) decision on March 17, 1980 after a review of 109 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Edwards Laboratories devices

Submission Details

510(k) Number K792441 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received November 29, 1979
Decision Date March 17, 1980
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRH Ring, Annuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
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.