Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3800](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3800) → KRH — Ring, Annuloplasty # KRH · Ring, Annuloplasty _Cardiovascular · 21 CFR 870.3800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH ## Overview - **Product Code:** KRH - **Device Name:** Ring, Annuloplasty - **Regulation:** [21 CFR 870.3800](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3800) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Implant:** yes ## Identification An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency. ## Classification Rationale Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.” ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.” ## Recent Cleared Devices (20 of 74) Showing 20 most recent of 74 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260498](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K260498.md) | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | Apr 14, 2026 | SESE | | [K253232](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K253232.md) | Seguin Annuloplasty Ring | ABBOTT MEDICAL | Oct 29, 2025 | SESE | | [K251982](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K251982.md) | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | Sep 23, 2025 | SESE | | [K251688](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K251688.md) | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | Sep 17, 2025 | SESE | | [K250859](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K250859.md) | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Jul 25, 2025 | SESE | | [K232599](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K232599.md) | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Apr 9, 2024 | SESE | | [K230679](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K230679.md) | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | May 26, 2023 | SESE | | [K230318](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K230318.md) | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | Corcym S.r.l. | Apr 7, 2023 | SESE | | [K202253](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K202253.md) | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | Oct 6, 2020 | SESE | | [K201449](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K201449.md) | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | Medtronic, Inc. | Jul 1, 2020 | SESE | | [K192762](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K192762.md) | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | Dec 16, 2019 | SESE | | [K190506](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K190506.md) | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | Apr 18, 2019 | SESE | | [K181132](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K181132.md) | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | May 29, 2018 | SESE | | [K180411](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K180411.md) | MEMO 4D | Sorin Group Italia S.R.L. | Mar 16, 2018 | SESE | | [K161815](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K161815.md) | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | Oct 12, 2016 | SESE | | [K142221](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K142221.md) | MEMO 3D ReChord | Sorin Group Italia S.R.L. | Aug 29, 2014 | SESE | | [K103520](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K103520.md) | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | Edwards Lifesciences, LLC | Jun 24, 2011 | SESE | | [K103812](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K103812.md) | MITRA-LIFT | Sciencity Co., Ltd. | May 18, 2011 | SESE | | [K101212](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K101212.md) | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | Medtronic, Inc. | Aug 7, 2010 | SESE | | [K093903](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K093903.md) | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | Genesee Biomedical, Inc. | Jul 15, 2010 | SESE | ## Top Applicants - Genesee Biomedical, Inc. — 13 clearances - Edwards Lifesciences, LLC — 9 clearances - St. Jude Medical, Inc. — 7 clearances - Baxter Healthcare Corp — 4 clearances - Medtronic Heart Valves — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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