Atlas FDA

KRH

75 FDA 510(k) clearances · Product code

77 daysmedian time to decision
206 days90th percentile
75clearances measured

FDA profile

Official device name
Ring, Annuloplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3800
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 423 · 2022: 372 · 2023: 324 · 2024: 407 · 2025: 425 · 2026: 264
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707)Corcym S.r.l.2026-06-18
TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498)Corcym S.r.l.2026-04-14
Seguin Annuloplasty Ring (K253232)ABBOTT MEDICAL2025-10-29
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982)Edwards Lifesciences, LLC2025-09-23
Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859)Genesee Biomedical, Inc.2025-07-25
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599)Genesee Biomedical, Inc.2024-04-09
WellsForm Tricuspid Annuloplasty Band (WF) (K230679)Genesee Biomedical, Inc.2023-05-26
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318)Corcym S.r.l.2023-04-07
TruForm Sievers Annuloplasty Ring (K202253)Genesee Biomedical, Inc.2020-10-06
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449)Medtronic, Inc.2020-07-01
Physio Flex Annuloplasty Ring (K192762)Edwards Lifesciences, LLC2019-12-16
NeoForm Annuloplasty Ring (K190506)Genesee Biomedical, Inc.2019-04-18
Tri-Ad 2.0 Adams Tricuspid Band (K181132)Medtronic2018-05-29
MEMO 4D (K180411)Sorin Group Italia S.R.L.2018-03-16
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band (K161815)Genesee Biomedical, Inc.2016-10-12
MEMO 3D ReChord (K142221)Sorin Group Italia S.R.L.2014-08-29
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING (K103520)Edwards Lifesciences, LLC2011-06-24
MITRA-LIFT (K103812)Sciencity Co., Ltd.2011-05-18
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R (K101212)Medtronic, Inc.2010-08-07
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC (K093903)Genesee Biomedical, Inc.2010-07-15
SJM ATTUNE ANNULOPLASTY RING (K092876)St Jude Medical2009-10-16
SEGUIN ANNULOPLASTY RING (K092310)St Jude Medical2009-08-27
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC (K090428)Genesee Biomedical, Inc.2009-05-07
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 (K083623)Edwards Lifesciences, LLC2009-04-15
DETLOGIX ANNULOPLASTY RING, MODEL: 5100 (K083191)Edwards Lifesciences, LLC2009-04-10
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (K083683)Genesee Biomedical, Inc.2009-02-25
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR (K083835)St Jude Medical2009-01-23
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 (K083470)Edwards Lifesciences, LLC2009-01-23
MICARDIA ANNULOPLASTY BAND DR (K070488)Micardia Corporation2008-09-04
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R (K073324)Medtronic, Inc.2008-03-13
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR (K072655)Genesee Biomedical, Inc.2007-10-23
MEMO 3D SEMIRIGID ANNULOPLASTY RING (K071327)Sorin Biomedica Cardio S.R.L.2007-08-10
UNIRING - ANNULOPLASTY RING WITH SIZERS (K071281)Peters Surgical2007-08-03
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING (K071214)Genesee Biomedical, Inc.2007-07-31
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R (K061127)Medtronic Vascular2006-05-23
SIMPLICI-T ANNULOPLASTY SYSTEM (K052970)Medtronic Heart Valves2006-01-11
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC (K052899)Genesee Biomedical, Inc.2005-11-17
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF (K052565)Genesee Biomedical, Inc.2005-11-17
CG FUTURE ANNULOPLASTY BAND (K052860)Medtronic Heart Valves2005-11-10
SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (K042734)St. Jude Medical, Inc.2004-12-17
NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 (K033685)Medical Cv, Inc.2004-08-03
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE (K032810)Medtronic Heart Valves2003-12-05
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 (K032250)Edwards Lifesciences, LLC2003-08-26
SHELHIGH BIORING (K023940)Shelhigh, Inc.2003-06-04
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 (K023185)Sulzer Carbomedics, Inc.2002-12-17
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) (K022363)St. Jude Medical, Inc.2002-09-19
ANNULOFLO SYSTEM, MITRAL MODEL AR700 (K021051)Sulzer Carbomedics, Inc.2002-04-23
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 (K020864)Edwards Lifesciences, LLC2002-04-17
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) (K014161)St. Jude Medical, Inc.2002-01-15
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) (K014037)St. Jude Medical, Inc.2002-01-04
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B (K011395)Medtronic Vascular2001-07-12
SJM TAILOR ANNULOPLASTY RING, MODEL TARN (K000119)St. Jude Medical, Inc.2000-02-17
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (K992056)Sulzer Carbomedics, Inc.1999-10-12
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M (K984435)Medtronic Vascular1999-01-07
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM (K980487)Baxter Edwards1998-07-07
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H (K980534)The Heart Valve Div. Medtronic Cardiovascular Surg1998-04-30
ANNULOFLO SYSTEM (K970375)Carbomedics, Inc.1997-07-25
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M (K961246)St. Jude Medical, Inc.1997-02-14
POSTERIOR ANNULOPLASTY BAND (MODEL 607) (K960356)The Heart Valve Div. Medtronic Cardiovascular Surg1996-08-27
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING (K926138)Baxter Healthcare Corp1993-06-22
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 (K923367)Baxter Healthcare Corp1993-01-06
PTI ANNULOPLASTY RING(STERILE) (K905175)Pioneering Technologies, Inc.1992-02-14
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS (K914972)Baxter Healthcare Corp1992-01-09
DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED (K914602)The Heart Valve Div. Medtronic Cardiovascular Surg1991-11-22
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI (K912554)Baxter Healthcare Corp1991-09-09
BIFLEX(TM) ANNULOPLASTY RING (K902159)St. Jude Medical, Inc.1991-01-18
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (K893678)Medtronic Blood Systems, Inc.1989-11-27
PROSTHETIC RINGS #4400 MITRAL & 4500 (K831949)American Edwards Laboratories1983-07-29
PUIG MASSANA-SHILEY ANNULOPLASTY RING (K821261)Shiley, Inc.1982-06-16
PUIG MASSANA-SHILEY ANNULOPLASTY RING (K801879)Shiley, Inc.1980-12-16
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. (K800147)Usifroid1980-04-24
CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (K792441)Edwards Laboratories1980-03-17
AMP DIRECT VASCULAR MONITORING SYSTEM (K792646)American Medical Products, Inc.1980-02-11
MERSILENE SUTURES (K790534)Hancock Laboratories, Inc.1979-03-26

Track KRH automatically

Every clearance here is in the API, with alerts when new ones post.