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/productcode/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](/device/K260498.md) | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | Apr 14, 2026 | SESE |
| [K253232](/device/K253232.md) | Seguin Annuloplasty Ring | ABBOTT MEDICAL | Oct 29, 2025 | SESE |
| [K251982](/device/K251982.md) | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | Sep 23, 2025 | SESE |
| [K251688](/device/K251688.md) | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | Sep 17, 2025 | SESE |
| [K250859](/device/K250859.md) | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Jul 25, 2025 | SESE |
| [K232599](/device/K232599.md) | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Apr 9, 2024 | SESE |
| [K230679](/device/K230679.md) | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | May 26, 2023 | SESE |
| [K230318](/device/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](/device/K202253.md) | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | Oct 6, 2020 | SESE |
| [K201449](/device/K201449.md) | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | Medtronic, Inc. | Jul 1, 2020 | SESE |
| [K192762](/device/K192762.md) | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | Dec 16, 2019 | SESE |
| [K190506](/device/K190506.md) | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | Apr 18, 2019 | SESE |
| [K181132](/device/K181132.md) | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | May 29, 2018 | SESE |
| [K180411](/device/K180411.md) | MEMO 4D | Sorin Group Italia S.R.L. | Mar 16, 2018 | SESE |
| [K161815](/device/K161815.md) | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | Oct 12, 2016 | SESE |
| [K142221](/device/K142221.md) | MEMO 3D ReChord | Sorin Group Italia S.R.L. | Aug 29, 2014 | SESE |
| [K103520](/device/K103520.md) | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | Edwards Lifesciences, LLC | Jun 24, 2011 | SESE |
| [K103812](/device/K103812.md) | MITRA-LIFT | Sciencity Co., Ltd. | May 18, 2011 | SESE |
| [K101212](/device/K101212.md) | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | Medtronic, Inc. | Aug 7, 2010 | SESE |
| [K093903](/device/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

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**Source:** [https://fda.innolitics.com/productcode/KRH](https://fda.innolitics.com/productcode/KRH)

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