Cleared Special

K020864 - EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM

K020864 is an FDA 510(k) clearance for EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Special 510(k) pathway after a 30-day FDA review.

K020864 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
30d
Days
Class 2
Risk

K020864 is an FDA 510(k) clearance for the EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K020864

510(k) Number K020864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date April 17, 2002
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K020864.
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
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · St. Jude Medical, Inc. · Sep 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · St. Jude Medical, Inc. · Jan 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · St. Jude Medical, Inc. · Jan 2002
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular · Jul 2001