Cleared Special

K093903 - ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC (FDA 510(k) Clearance)

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

K093903 · Genesee Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
205d
Days
Class 2
Risk

K093903 is an FDA 510(k) clearance for the ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC. 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 July 15, 2010 after a review of 205 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. 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. Standard predicate reliance. 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 K093903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date July 15, 2010
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 73
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K093903.
TriMemo™ SEMIRIGID ANNULOPLASTY RING
K260498 · Corcym S.r.l. · Apr 2026
Seguin Annuloplasty Ring
K253232 · Abbott Medical · Oct 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
K251982 · Edwards Lifesciences, LLC · Sep 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
K251688 · Edwards Lifesciences, LLC · Sep 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · Genesee Biomedical, Inc. · Jul 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · Genesee Biomedical, Inc. · Apr 2024