Cleared Traditional

K914602 - DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

K914602 is an FDA 510(k) clearance for DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, manufactured by The Heart Valve Div. Medtronic Cardiovascular Surg. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K914602 · The Heart Valve Div. Medtronic Cardiovascular Surg · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
38d
Days
Class 2
Risk

K914602 is an FDA 510(k) clearance for the DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by The Heart Valve Div. Medtronic Cardiovascular Surg (Minneapolis, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Heart Valve Div. Medtronic Cardiovascular Surg devices

FDA 510(k) Submission Details - K914602

510(k) Number K914602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1991
Decision Date November 22, 1991
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 49
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K914602.
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993
PTI ANNULOPLASTY RING(STERILE)
K905175 · Pioneering Technologies, Inc. · Feb 1992
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
BIFLEX(TM) ANNULOPLASTY RING
K902159 · St. Jude Medical, Inc. · Jan 1991
PROSTHETIC RINGS #4400 MITRAL & 4500
K831949 · American Edwards Laboratories · Jul 1983