Cleared Traditional

CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 (K083470) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083470 · Edwards Lifesciences, LLC · Cardiovascular device
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Jan 2009
Decision
60d
Days
Class 2
Risk

K083470 is an FDA 510(k) clearance for the CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200. 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 January 23, 2009 after a review of 60 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 Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K083470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date January 23, 2009
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K083470.
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · Medtronic, Inc. · Aug 2010
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
K083623 · Edwards Lifesciences, LLC · Apr 2009
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · Edwards Lifesciences, LLC · Apr 2009
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc. · Mar 2008
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003