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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: MEB FDA class 2

    Pump, Infusion, Elastomeric

    General Hospital

    View full classification →

    The elastomeric infusion pump is a general hospital device that uses the elastic properties of a balloon reservoir to deliver intravenous medications or fluids at a controlled rate without requiring electronic power, commonly used for outpatient infusion therapy. 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 MEB and the device is not implanted. Full GMP quality system requirements apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    InfuLife
    SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
    ON-Q* Pump with Bolus
    SMARTez elastomeric infusion pump
    ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
    MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
    MODIFICATION TO AUTOFUSER
    ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
    ALPHA INFUSION PUMP, MODEL A200, A450
    DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
    SMARTBLOCK PAIN PUMP
    MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
    INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
    ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
    STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
    INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
    SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
    AUTOFUSER
    SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
    SEMPERFLO INFUSION SYSTEM
    NIPRO SUREFUSER AMBULATORY INFUSION PUMP
    MPS ACACIA MEDFLO ELASTOMERIC PUMP
    I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
    SYMBIOS DISPOSABLE INFUSION PUMP KIT
    MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
    SMARTINFUSER PAINPUMP
    MULTI-DRIP INFUSION CATHETER
    AUTOFUSER AMBULATORY INFUSION PUMP
    I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
    DOSI-FUSER
    MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
    B. BRAUN NERVE BLOCK CATHETER
    HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
    ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
    I-FLOW ELASTOMERIC PUMP WITH BOLUS
    ALPHA INFUSION PUMP AND CATHETERS
    PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
    PAIN CARE 4200
    I-FLOW ELASTOMERIC PUMP
    HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
    PAIN CARE 3200
    MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
    MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM
    PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
    ACCUFUSER; ACCUFUSER PLUS
    MPS ACACIA PAIN KIT
    PAIN CARE 3000
    P.O.P. PAIN KIT
    PAIN CARE 2000L
    GO MEDICAL BALLOON INFUSION SYSTEM

    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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