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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: FKX FDA class 2

    System, Peritoneal, Automatic Delivery

    Gastroenterology, Urology

    View full classification →

    The Automatic Peritoneal Delivery System is a device that mechanically controls the infusion and drainage of dialysate fluid into and out of the peritoneal cavity during automated peritoneal dialysis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKX, regulated under 21 CFR 876.5630 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
    Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
    Fresenius Liberty Select Cycler
    Lilliput APD System
    CloudCath Peritoneal Dialysis Drain Set Monitoring System
    Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
    Fresenius Liberty Select Cycler
    Liberty Cycler Set
    Fresenius Liberty Select Cycler
    Amia Automated PD System with Sharesource
    LIBERTY PDX CYCLER
    FRESENIUS LIBERTY CYCLER
    AMIA AUTOMATED PD SYSTEM
    VOYAGER PERITONEAL DIALYSIS SYSTEM
    HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
    HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
    FRESENIUS LIBERTY CYCLER
    HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
    FRSENIUS PD IQCARD CYCLER
    EASY CARE AND TUBING SETS
    BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
    BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
    R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
    NMC CYCLER MACHINE
    SELECTRA AND TUBING SETS
    FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
    DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
    DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
    MULTI-STRIP
    ABBOTT INPERSOL CYCLER 1000
    PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
    BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
    UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    AMUKIN-50% FOR CAPD Y-SET
    ABBOTT INPERSOL CYCLER 1000
    ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
    AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
    RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
    SCD STERILE CONNECTION DEVICE
    EXTENDED LIFE CAPD SOLUTION TRANSFER
    LIFEMED LIFECOIL CATHETERS
    C.A.P.D. AUTOMATIC HEATER PDH 200
    EXTENDED LIFE CAPD SOLUTION TRANSFER
    PERITONEAL CATHETER-CHANGES-
    CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
    AUTOMATIC PERITONEAL DIALYSIS CYCLER
    MICROSTAR VCI
    MICROSTAR VC1 VOLUMETRIC CYCLER
    CAPD - CATHETER ADAPTER
    AMPERCIDE DISINFECTANT ACCESSORY TO -

    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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