Product Code: KRH FDA class 2 21 CFR 870.3800

Ring, Annuloplasty

Cardiovascular

This device is an annuloplasty ring, a surgical implant used to repair and reshape a diseased or insufficient heart valve annulus, typically the mitral or tricuspid valve, restoring proper valve geometry and function. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRH, regulated under 21 CFR 870.3800 within the Cardiovascular specialty. This device is designated as an implant, as it is permanently placed within the heart.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KRH
Device Class: FDA class 2
Regulation Number: 870.3800
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 75 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261707	MEMO 4D Curve Semirigid mitral annuloplasty ring	Jun 18, 2026	Substantially Equivalent	Corcym S.r.l.
K260498	TriMemo SEMIRIGID ANNULOPLASTY RING	Apr 14, 2026	Substantially Equivalent	Corcym S.r.l.
K253232	Seguin Annuloplasty Ring	Oct 29, 2025	Substantially Equivalent	ABBOTT MEDICAL
K251982	Edwards MC3 Tricuspid annuloplasty ring (4900)	Sep 23, 2025	Substantially Equivalent	Edwards Lifesciences, LLC
K251688	Carpentier-Edwards Physio Annuloplasty Ring (4450)	Sep 17, 2025	Substantially Equivalent	Edwards Lifesciences, LLC
K250859	TransForm McCarthy Mitral Annuloplasty Ring (TF)	Jul 25, 2025	Substantially Equivalent	Genesee Biomedical, Inc.
K232599	TransForm McCarthy Mitral Annuloplasty Ring (TF)	Apr 09, 2024	Substantially Equivalent	Genesee Biomedical, Inc.
K230679	WellsForm Tricuspid Annuloplasty Band (WF)	May 26, 2023	Substantially Equivalent	Genesee Biomedical, Inc.
K230318	Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring	Apr 07, 2023	Substantially Equivalent	Corcym S.r.l.
K202253	TruForm Sievers Annuloplasty Ring	Oct 06, 2020	Substantially Equivalent	Genesee Biomedical, Inc.
K201449	SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring	Jul 01, 2020	Substantially Equivalent	Medtronic, Inc.
K192762	Physio Flex Annuloplasty Ring	Dec 16, 2019	Substantially Equivalent	Edwards Lifesciences, LLC
K190506	NeoForm Annuloplasty Ring	Apr 18, 2019	Substantially Equivalent	Genesee Biomedical, Inc.
K181132	Tri-Ad 2.0 Adams Tricuspid Band	May 29, 2018	Substantially Equivalent	Medtronic
K180411	MEMO 4D	Mar 16, 2018	Substantially Equivalent	Sorin Group Italia S.R.L.
K161815	FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band	Oct 12, 2016	Substantially Equivalent	Genesee Biomedical, Inc.
K142221	MEMO 3D ReChord	Aug 29, 2014	Substantially Equivalent	Sorin Group Italia S.R.L.
K103520	CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING	Jun 24, 2011	Substantially Equivalent	Edwards Lifesciences, LLC
K103812	MITRA-LIFT	May 18, 2011	Substantially Equivalent	Sciencity Co., Ltd.
K101212	MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R	Aug 07, 2010	Substantially Equivalent	Medtronic, Inc.
K093903	ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC	Jul 15, 2010	Substantially Equivalent	Genesee Biomedical, Inc.
K092876	SJM ATTUNE ANNULOPLASTY RING	Oct 16, 2009	Substantially Equivalent	St Jude Medical
K092310	SEGUIN ANNULOPLASTY RING	Aug 27, 2009	Substantially Equivalent	St Jude Medical
K090428	ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC	May 07, 2009	Substantially Equivalent	Genesee Biomedical, Inc.
K083623	CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100	Apr 15, 2009	Substantially Equivalent	Edwards Lifesciences, LLC
K083191	DETLOGIX ANNULOPLASTY RING, MODEL: 5100	Apr 10, 2009	Substantially Equivalent	Edwards Lifesciences, LLC
K083683	ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC	Feb 25, 2009	Substantially Equivalent	Genesee Biomedical, Inc.
K083835	ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR	Jan 23, 2009	Substantially Equivalent	St Jude Medical
K083470	CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200	Jan 23, 2009	Substantially Equivalent	Edwards Lifesciences, LLC
K070488	MICARDIA ANNULOPLASTY BAND DR	Sep 04, 2008	Substantially Equivalent	Micardia Corporation
K073324	MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R	Mar 13, 2008	Substantially Equivalent	Medtronic, Inc.
K072655	ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR	Oct 23, 2007	Substantially Equivalent	Genesee Biomedical, Inc.
K071327	MEMO 3D SEMIRIGID ANNULOPLASTY RING	Aug 10, 2007	Substantially Equivalent	Sorin Biomedica Cardio S.R.L.
K071281	UNIRING - ANNULOPLASTY RING WITH SIZERS	Aug 03, 2007	Substantially Equivalent	Peters Surgical
K071214	ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING	Jul 31, 2007	Substantially Equivalent	Genesee Biomedical, Inc.
K061127	CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R	May 23, 2006	Substantially Equivalent	Medtronic Vascular
K052970	SIMPLICI-T ANNULOPLASTY SYSTEM	Jan 11, 2006	Substantially Equivalent	Medtronic Heart Valves
K052899	ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC	Nov 17, 2005	Substantially Equivalent	Genesee Biomedical, Inc.
K052565	ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF	Nov 17, 2005	Substantially Equivalent	Genesee Biomedical, Inc.
K052860	CG FUTURE ANNULOPLASTY BAND	Nov 10, 2005	Substantially Equivalent	Medtronic Heart Valves
K042734	SJM RIGID SADDLE RING MODEL RSAR-(SIZE)	Dec 17, 2004	Substantially Equivalent	St. Jude Medical, Inc.
K033685	NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000	Aug 03, 2004	Substantially Equivalent	Medical Cv, Inc.
K032810	DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE	Dec 05, 2003	Substantially Equivalent	Medtronic Heart Valves
K032250	GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200	Aug 26, 2003	Substantially Equivalent	Edwards Lifesciences, LLC
K023940	SHELHIGH BIORING	Jun 04, 2003	Substantially Equivalent	Shelhigh, Inc.
K023185	ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800	Dec 17, 2002	Substantially Equivalent	Sulzer Carbomedics, Inc.
K022363	SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)	Sep 19, 2002	Substantially Equivalent	St. Jude Medical, Inc.
K021051	ANNULOFLO SYSTEM, MITRAL MODEL AR700	Apr 23, 2002	Substantially Equivalent	Sulzer Carbomedics, Inc.
K020864	EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900	Apr 17, 2002	Substantially Equivalent	Edwards Lifesciences, LLC
K014161	SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)	Jan 15, 2002	Substantially Equivalent	St. Jude Medical, Inc.
K014037	SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)	Jan 04, 2002	Substantially Equivalent	St. Jude Medical, Inc.
K011395	MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B	Jul 12, 2001	Substantially Equivalent	Medtronic Vascular
K000119	SJM TAILOR ANNULOPLASTY RING, MODEL TARN	Feb 17, 2000	Substantially Equivalent	St. Jude Medical, Inc.
K992056	ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800	Oct 12, 1999	Substantially Equivalent	Sulzer Carbomedics, Inc.
K984435	MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M	Jan 07, 1999	Substantially Equivalent	Medtronic Vascular
K980487	CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM	Jul 07, 1998	Substantially Equivalent	Baxter Edwards
K980534	DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H	Apr 30, 1998	Substantially Equivalent	The Heart Valve Div. Medtronic Cardiovascular Surg
K970375	ANNULOFLO SYSTEM	Jul 25, 1997	Substantially Equivalent - Subject to Tracking Reg.	Carbomedics, Inc.
K961246	SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M	Feb 14, 1997	Substantially Equivalent - Subject to Tracking Reg.	St. Jude Medical, Inc.
K960356	POSTERIOR ANNULOPLASTY BAND (MODEL 607)	Aug 27, 1996	Substantially Equivalent - Subject to Tracking Reg.	The Heart Valve Div. Medtronic Cardiovascular Surg
K926138	CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING	Jun 22, 1993	Unknown	Baxter Healthcare Corp
K923367	COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600	Jan 06, 1993	Unknown	Baxter Healthcare Corp
K905175	PTI ANNULOPLASTY RING(STERILE)	Feb 14, 1992	Substantially Equivalent	Pioneering Technologies, Inc.
K914972	CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS	Jan 09, 1992	Substantially Equivalent	Baxter Healthcare Corp
K914602	DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED	Nov 22, 1991	Substantially Equivalent	The Heart Valve Div. Medtronic Cardiovascular Surg
K912554	ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI	Sep 09, 1991	Substantially Equivalent	Baxter Healthcare Corp
K902159	BIFLEX(TM) ANNULOPLASTY RING	Jan 18, 1991	Substantially Equivalent	St. Jude Medical, Inc.
K893678	DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H	Nov 27, 1989	Substantially Equivalent	Medtronic Blood Systems, Inc.
K831949	PROSTHETIC RINGS #4400 MITRAL & 4500	Jul 29, 1983	Substantially Equivalent - Subject to Tracking & PMS	American Edwards Laboratories
K821261	PUIG MASSANA-SHILEY ANNULOPLASTY RING	Jun 16, 1982	Substantially Equivalent	Shiley, Inc.
K801879	PUIG MASSANA-SHILEY ANNULOPLASTY RING	Dec 16, 1980	Substantially Equivalent	Shiley, Inc.
K800147	FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.	Apr 24, 1980	Substantially Equivalent	Usifroid
K792441	CARPENTIER-EDWARDS FLEX. ANNULOPLASTY	Mar 17, 1980	Substantially Equivalent - Subject to Tracking & PMS	Edwards Laboratories
K792646	AMP DIRECT VASCULAR MONITORING SYSTEM	Feb 11, 1980	Substantially Equivalent	American Medical Products, Inc.
K790534	MERSILENE SUTURES	Mar 26, 1979	Substantially Equivalent	Hancock Laboratories, Inc.