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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: KRH FDA class 2

    Ring, Annuloplasty

    Cardiovascular

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TransForm McCarthy Mitral Annuloplasty Ring (TF)
    WellsForm Tricuspid Annuloplasty Band (WF)
    Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
    TruForm Sievers Annuloplasty Ring
    SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
    Physio Flex Annuloplasty Ring
    NeoForm Annuloplasty Ring
    Tri-Ad 2.0 Adams Tricuspid Band
    MEMO 4D
    FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
    MEMO 3D ReChord
    CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
    MITRA-LIFT
    MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
    ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
    SJM ATTUNE ANNULOPLASTY RING
    SEGUIN ANNULOPLASTY RING
    ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
    DETLOGIX ANNULOPLASTY RING, MODEL: 5100
    ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
    ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
    CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
    MICARDIA ANNULOPLASTY BAND DR
    MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
    ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
    MEMO 3D SEMIRIGID ANNULOPLASTY RING
    UNIRING - ANNULOPLASTY RING WITH SIZERS
    ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
    CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
    SIMPLICI-T ANNULOPLASTY SYSTEM
    ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
    ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
    CG FUTURE ANNULOPLASTY BAND
    SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
    NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
    DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
    GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
    SHELHIGH BIORING
    ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
    SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
    ANNULOFLO SYSTEM, MITRAL MODEL AR700
    EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
    SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
    SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
    MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
    SJM TAILOR ANNULOPLASTY RING, MODEL TARN
    ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
    MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
    CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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