Cleared Traditional

K073324 - MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R

K073324 is an FDA 510(k) clearance for MEDTRONIC PROFILE 3D ANNULOPLASTY RING, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K073324 · Medtronic, Inc. · Cardiovascular device
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Mar 2008
Decision
107d
Days
Class 2
Risk

K073324 is an FDA 510(k) clearance for the MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 13, 2008 after a review of 107 days - within the typical 510(k) review window.

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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K073324

510(k) Number K073324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2007
Decision Date March 13, 2008
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
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 52
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K073324.
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · Edwards Lifesciences, LLC · Apr 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · Edwards Lifesciences, LLC · Jan 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · St Jude Medical · Jan 2009
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
K042734 · St. Jude Medical, Inc. · Dec 2004
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003