Cleared Traditional

K161815 - FlexForm Annuloplasty Ring and FlexForm...

K161815 is an FDA 510(k) clearance for FlexForm Annuloplasty Ring and FlexForm..., manufactured by Genesee Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K161815 · Genesee Biomedical, Inc. · Cardiovascular device
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Oct 2016
Decision
103d
Days
Class 2
Risk

K161815 is an FDA 510(k) clearance for the FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band. 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 October 12, 2016 after a review of 103 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 Genesee Biomedical, Inc. devices

FDA 510(k) Submission Details - K161815

510(k) Number K161815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date October 12, 2016
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 125d · This submission: 103d
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 44
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K161815.
NeoForm Annuloplasty Ring
K190506 · Genesee Biomedical, Inc. · Apr 2019
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
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K103520 · Edwards Lifesciences, LLC · Jun 2011
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · Medtronic, Inc. · Aug 2010