Cleared Traditional

K101212 - MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

K101212 is an FDA 510(k) clearance for MEDTRONIC CONTOUR 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 99-day FDA review.

K101212 · Medtronic, Inc. · Cardiovascular device
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Aug 2010
Decision
99d
Days
Class 2
Risk

K101212 is an FDA 510(k) clearance for the MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on August 7, 2010 after a review of 99 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 - K101212

510(k) Number K101212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2010
Decision Date August 07, 2010
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 51
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K101212.
MEMO 3D ReChord
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CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
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MITRA-LIFT
K103812 · Sciencity Co., Ltd. · May 2011
SJM ATTUNE ANNULOPLASTY RING
K092876 · St Jude Medical · Oct 2009
SEGUIN ANNULOPLASTY RING
K092310 · St Jude Medical · Aug 2009
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
K083623 · Edwards Lifesciences, LLC · Apr 2009