Not Cleared Traditional

K831949 - PROSTHETIC RINGS #4400 MITRAL & 4500 (FDA 510(k) Clearance)

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

K831949 · American Edwards Laboratories · Cardiovascular device
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Jul 1983
Decision
43d
Days
Class 2
Risk

K831949 is an FDA 510(k) submission (not cleared) for the PROSTHETIC RINGS #4400 MITRAL & 4500. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Not Cleared (DENG) decision on July 29, 1983 after a review of 43 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 American Edwards Laboratories devices

Submission Details

510(k) Number K831949 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received June 16, 1983
Decision Date July 29, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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.

Regulatory Peers - KRH Ring, Annuloplasty

All 73
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