Cleared Traditional

K250859 - TransForm McCarthy Mitral Annuloplasty Ring (TF) (FDA 510(k) Clearance)

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

K250859 · Genesee Biomedical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
126d
Days
Class 2
Risk

K250859 is an FDA 510(k) clearance for the TransForm McCarthy Mitral Annuloplasty Ring (TF). 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 25, 2025 after a review of 126 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

Submission Details

510(k) Number K250859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2025
Decision Date July 25, 2025
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
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 73
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K250859.
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)
K232599 · Genesee Biomedical, Inc. · Apr 2024
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · Genesee Biomedical, Inc. · May 2023