Cleared Abbreviated

K251982 - Edwards MC3 Tricuspid annuloplasty ring (4900) (FDA 510(k) Clearance)

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

K251982 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
88d
Days
Class 2
Risk

K251982 is an FDA 510(k) clearance for the Edwards MC3 Tricuspid annuloplasty ring (4900). Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on September 23, 2025 after a review of 88 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K251982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2025
Decision Date September 23, 2025
Days to Decision 88 days
Submission Type Abbreviated
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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

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 K251982.
TriMemo™ SEMIRIGID ANNULOPLASTY RING
K260498 · Corcym S.r.l. · Apr 2026
Seguin Annuloplasty Ring
K253232 · Abbott Medical · Oct 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
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · Genesee Biomedical, Inc. · May 2023