FDA Product Code KRH: Ring, Annuloplasty
Annuloplasty rings restore mitral valve geometry and competence in mitral regurgitation surgery. FDA product code KRH covers annuloplasty rings used in heart valve repair.
These rigid or flexible rings are sewn to the mitral or tricuspid annulus to reduce annular diameter, restore the normal saddle-shaped geometry, and support the valve leaflets, enabling durable repair of regurgitant valves while preserving native valve tissue.
KRH devices are Class II medical devices, regulated under 21 CFR 870.3800 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Genesee Biomedical, Inc., Baxter Healthcare Corp and Medtronic Vascular.
74
Total
72
Cleared
103d
Avg days
1979
Since
Growing category -
5 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
82d
recently vs 104d historically
FDA 510(k) Cleared Ring, Annuloplasty Devices (Product Code KRH)
74 devices
Cleared
Apr 14, 2026
TriMemo™ SEMIRIGID ANNULOPLASTY RING
Corcym S.r.l.
Cardiovascular
60d
Cleared
Oct 29, 2025
Seguin Annuloplasty Ring
Abbott Medical
Cardiovascular
30d
Cleared
Sep 23, 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
Edwards Lifesciences, LLC
Cardiovascular
88d
Cleared
Sep 17, 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
Edwards Lifesciences, LLC
Cardiovascular
107d
Cleared
Jul 25, 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Genesee Biomedical, Inc.
Cardiovascular
126d
Cleared
Apr 09, 2024
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Genesee Biomedical, Inc.
Cardiovascular
225d
Cleared
May 26, 2023
WellsForm Tricuspid Annuloplasty Band (WF)
Genesee Biomedical, Inc.
Cardiovascular
74d
Cleared
Apr 07, 2023
Memo 3D Semirigid Annuloplasty Ring
Corcym S.r.l.
Cardiovascular
60d
Cleared
Oct 06, 2020
TruForm Sievers Annuloplasty Ring
Genesee Biomedical, Inc.
Cardiovascular
57d
Cleared
Jul 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
Medtronic, Inc.
Cardiovascular
30d
Cleared
Dec 16, 2019
Physio Flex Annuloplasty Ring
Edwards Lifesciences, LLC
Cardiovascular
77d
Cleared
Apr 18, 2019
NeoForm Annuloplasty Ring
Genesee Biomedical, Inc.
Cardiovascular
48d
Cleared
May 29, 2018
Tri-Ad 2.0 Adams Tricuspid Band
Medtronic
Cardiovascular
29d
Cleared
Mar 16, 2018
MEMO 4D
Sorin Group Italia S.R.L.
Cardiovascular
29d
Cleared
May 23, 2006
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
Medtronic Vascular
Cardiovascular
29d
Cleared
Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
Medtronic Vascular
Cardiovascular
66d
Cleared
Jan 07, 1999
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
Medtronic Vascular
Cardiovascular
27d
Cleared
Jun 22, 1993
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
Baxter Healthcare Corp
Cardiovascular
197d
Cleared
Jan 06, 1993
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
Baxter Healthcare Corp
Cardiovascular
181d
Cleared
Jan 09, 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
Baxter Healthcare Corp
Cardiovascular
64d
Cleared
Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
Baxter Healthcare Corp
Cardiovascular
90d
About Product Code KRH - Regulatory Context
510(k) Submission Activity
74 total 510(k) submissions under product code KRH since 1979, with 72 receiving FDA clearance (average review time: 103 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - KRH Product Code
Recent submissions under KRH have taken an average of 82 days to reach a decision - down from 104 days historically, suggesting improved FDA processing for this classification.
KRH devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →