Cleared Traditional

K902159 - BIFLEX(TM) ANNULOPLASTY RING

K902159 is an FDA 510(k) clearance for BIFLEX(TM) ANNULOPLASTY RING, manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K902159 · St. Jude Medical, Inc. · Cardiovascular device
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Jan 1991
Decision
248d
Days
Class 2
Risk

K902159 is an FDA 510(k) clearance for the BIFLEX(TM) ANNULOPLASTY RING. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 248 days - an extended review cycle.

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 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 St. Jude Medical, Inc. devices

FDA 510(k) Submission Details - K902159

510(k) Number K902159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date January 18, 1991
Days to Decision 248 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
123d slower than avg
Panel avg: 125d · This submission: 248d
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 44
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K902159.
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · Baxter Healthcare Corp · Jan 1992
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · Baxter Healthcare Corp · Sep 1991
PROSTHETIC RINGS #4400 MITRAL & 4500
K831949 · American Edwards Laboratories · Jul 1983
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K821261 · Shiley, Inc. · Jun 1982
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879 · Shiley, Inc. · Dec 1980