Cleared Special

ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (K083683) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083683 · Genesee Biomedical, Inc. · Cardiovascular device
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Feb 2009
Decision
75d
Days
Class 2
Risk

K083683 is an FDA 510(k) clearance for the ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Genesee Biomedical, Inc. (Denver, US). The FDA issued a Cleared decision on February 25, 2009 after a review of 75 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 Genesee Biomedical, Inc. devices

Submission Details

510(k) Number K083683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2008
Decision Date February 25, 2009
Days to Decision 75 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K083683.
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
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · Edwards Lifesciences, LLC · Jan 2009
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc. · Mar 2008
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006