Cleared Traditional

NeoForm Annuloplasty Ring (K190506) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190506 · Genesee Biomedical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
48d
Days
Class 2
Risk

K190506 is an FDA 510(k) clearance for the NeoForm Annuloplasty Ring. 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 April 18, 2019 after a review of 48 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genesee Biomedical, Inc. devices

Submission Details

510(k) Number K190506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date April 18, 2019
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K190506.
TruForm Sievers Annuloplasty Ring
K202253 · Genesee Biomedical, Inc. · Oct 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
K201449 · Medtronic, Inc. · Jul 2020
Physio Flex Annuloplasty Ring
K192762 · Edwards Lifesciences, LLC · Dec 2019
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · Medtronic · May 2018
MEMO 4D
K180411 · Sorin Group Italia S.R.L. · Mar 2018
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K103520 · Edwards Lifesciences, LLC · Jun 2011