Not Cleared Traditional

K831949 - PROSTHETIC RINGS #4400 MITRAL & 4500

K831949 is an FDA 510(k) submission for PROSTHETIC RINGS #4400 MITRAL & 4500, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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.

FDA 510(k) Submission Details - K831949

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
Combination Product No
PCCP Authorized No
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.

KRH Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K831949.
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · Baxter Healthcare Corp · Sep 1991
BIFLEX(TM) ANNULOPLASTY RING
K902159 · St. Jude Medical, Inc. · Jan 1991
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
K893678 · Medtronic Blood Systems, Inc. · Nov 1989
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K821261 · Shiley, Inc. · Jun 1982
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879 · Shiley, Inc. · Dec 1980
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.
K800147 · Usifroid · Apr 1980
K831949 · PROSTHETIC RINGS #4400 MITRAL & 4500
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