Cleared Special

K090428 - ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOP...

K090428 is an FDA 510(k) clearance for ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOP..., manufactured by Genesee Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Special 510(k) pathway after a 77-day FDA review.

K090428 · Genesee Biomedical, Inc. · Cardiovascular device
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May 2009
Decision
77d
Days
Class 2
Risk

K090428 is an FDA 510(k) clearance for the ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC. 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 May 7, 2009 after a review of 77 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

FDA 510(k) Submission Details - K090428

510(k) Number K090428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date May 07, 2009
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 44
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K090428.
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
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