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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: MEA FDA class 2

    Pump, Infusion, Pca

    General Hospital

    View full classification →

    The patient-controlled analgesia (PCA) infusion pump is a general hospital device that allows patients to self-administer controlled doses of analgesic medication within preset safety limits, used for acute pain management in postoperative and other clinical settings. It is classified as FDA Class II under 21 CFR 880.5725 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MEA and the device is not implanted. Full GMP compliance is required.

    510(k) Clearances

    31 matches
    K Number
    Device Name
    ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
    CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
    LifeCare PCA Infusion System
    CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
    PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
    CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
    MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
    MEDLEY PCA MODULE, MODEL 8120
    HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
    LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
    HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
    MEDLEY PCA MODULE, MODEL 8120
    SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
    STRYKER PAINPUMP2
    GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
    MICROJET CRONO PCA
    INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
    PALM PUMP
    AVIA PAIN MEDICATION DELIVERY SYSTEM
    CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
    MODEL 6100 AMBULATORY INFUSION SYSTEM
    VERIFUSE AMBULATORY PUMP
    PRIME PCA AND PCA/CONTINUOUS SYSTEMS
    PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
    BARD PCA II PUMP WITH PROGRAM CARTRIDGES
    IVAC PC ANIFUSER
    BARD PCA II PUMP WITH PROGRAM CARTRIDGES
    BAXA PCA INFUSOR
    CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

    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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