Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KRH — Predicate Candidate Screening
75 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
206 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | Corcym S.r.l. | 2026-06-18 | 27 | 0 |
| K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | 2026-04-14 | 60 | 0 |
| K253232 | Seguin Annuloplasty Ring | ABBOTT MEDICAL | 2025-10-29 | 30 | 0 |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | 2025-09-23 | 88 | 0 |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | 2025-09-17 | 107 | 0 |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2025-07-25 | 126 | 0 |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2024-04-09 | 225 | 0 |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | 2023-05-26 | 74 | 0 |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirig | Corcym S.r.l. | 2023-04-07 | 60 | 0 |
| K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | 2020-10-06 | 57 | 0 |
| K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annul | Medtronic, Inc. | 2020-07-01 | 30 | 0 |
| K192762 | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | 2019-12-16 | 77 | 0 |
| K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | 2019-04-18 | 48 | 0 |
| K181132 | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | 2018-05-29 | 29 | 0 |
| K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018-03-16 | 29 | 0 |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | 2016-10-12 | 103 | 0 |
| K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014-08-29 | 17 | 0 |
| K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | Edwards Lifesciences, LLC | 2011-06-24 | 206 | 0 |
| K103812 | MITRA-LIFT | Sciencity Co., Ltd. | 2011-05-18 | 140 | 0 |
| K101212 | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | Medtronic, Inc. | 2010-08-07 | 99 | 0 |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SF | Genesee Biomedical, Inc. | 2010-07-15 | 205 | 0 |
| K092876 | SJM ATTUNE ANNULOPLASTY RING | St Jude Medical | 2009-10-16 | 28 | 0 |
| K092310 | SEGUIN ANNULOPLASTY RING | St Jude Medical | 2009-08-27 | 29 | 0 |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | Genesee Biomedical, Inc. | 2009-05-07 | 77 | 0 |
| K083623 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MOD | Edwards Lifesciences, LLC | 2009-04-15 | 128 | 0 |
| K083191 | DETLOGIX ANNULOPLASTY RING, MODEL: 5100 | Edwards Lifesciences, LLC | 2009-04-10 | 163 | 0 |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | Genesee Biomedical, Inc. | 2009-02-25 | 75 | 0 |
| K083835 | ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR | St Jude Medical | 2009-01-23 | 31 | 0 |
| K083470 | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 | Edwards Lifesciences, LLC | 2009-01-23 | 60 | 0 |
| K070488 | MICARDIA ANNULOPLASTY BAND DR | Micardia Corporation | 2008-09-04 | 562 | 0 |
| K073324 | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R | Medtronic, Inc. | 2008-03-13 | 107 | 0 |
| K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | Genesee Biomedical, Inc. | 2007-10-23 | 33 | 0 |
| K071327 | MEMO 3D SEMIRIGID ANNULOPLASTY RING | Sorin Biomedica Cardio S.R.L. | 2007-08-10 | 91 | 0 |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Peters Surgical | 2007-08-03 | 88 | 0 |
| K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | Genesee Biomedical, Inc. | 2007-07-31 | 91 | 0 |
| K061127 | CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R | Medtronic Vascular | 2006-05-23 | 29 | 0 |
| K052970 | SIMPLICI-T ANNULOPLASTY SYSTEM | Medtronic Heart Valves | 2006-01-11 | 79 | 0 |
| K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | Genesee Biomedical, Inc. | 2005-11-17 | 34 | 0 |
| K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | Genesee Biomedical, Inc. | 2005-11-17 | 59 | 0 |
| K052860 | CG FUTURE ANNULOPLASTY BAND | Medtronic Heart Valves | 2005-11-10 | 30 | 0 |
| K042734 | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) | St. Jude Medical, Inc. | 2004-12-17 | 77 | 0 |
| K033685 | NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 | Medical Cv, Inc. | 2004-08-03 | 253 | 0 |
| K032810 | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAN | Medtronic Heart Valves | 2003-12-05 | 87 | 0 |
| K032250 | GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 | Edwards Lifesciences, LLC | 2003-08-26 | 35 | 0 |
| K023940 | SHELHIGH BIORING | Shelhigh, Inc. | 2003-06-04 | 190 | 0 |
| K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | Sulzer Carbomedics, Inc. | 2002-12-17 | 84 | 0 |
| K022363 | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) | St. Jude Medical, Inc. | 2002-09-19 | 59 | 0 |
| K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | Sulzer Carbomedics, Inc. | 2002-04-23 | 22 | 0 |
| K020864 | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 | Edwards Lifesciences, LLC | 2002-04-17 | 30 | 0 |
| K014161 | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) | St. Jude Medical, Inc. | 2002-01-15 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda