Cleared Traditional

K103520 - CARPENTIER-EDWARDS PHYSIO TRICUSPID ANN...

K103520 is an FDA 510(k) clearance for CARPENTIER-EDWARDS PHYSIO TRICUSPID ANN..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K103520 · Edwards Lifesciences, LLC · Cardiovascular device
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Jun 2011
Decision
206d
Days
Class 2
Risk

K103520 is an FDA 510(k) clearance for the CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING. 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 June 24, 2011 after a review of 206 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K103520

510(k) Number K103520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2010
Decision Date June 24, 2011
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
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 42
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K103520.
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · Medtronic · May 2018
MEMO 4D
K180411 · Sorin Group Italia S.R.L. · Mar 2018
MEMO 3D ReChord
K142221 · Sorin Group Italia S.R.L. · Aug 2014
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · Medtronic, Inc. · Aug 2010
SJM ATTUNE ANNULOPLASTY RING
K092876 · St Jude Medical · Oct 2009
SEGUIN ANNULOPLASTY RING
K092310 · St Jude Medical · Aug 2009