BEUDAMED
    Product Code: MEA FDA class 2 21 CFR 880.5725

    Pump, Infusion, Pca

    General Hospital

    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.

    View on FDA
    510(k)s
    31
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    24
    Years Active
    26

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    Basic Information

    Product Code
    MEA
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 31 510(k) clearances via K numbers.

    K Number Device Name
    K162165 ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
    K170982 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)
    K143612 LifeCare PCA Infusion System
    K130394 CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
    K092313 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
    K072144 CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
    K051253 MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
    K043299 MEDLEY PCA MODULE, MODEL 8120
    K043256 HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
    K042800 LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
    K033054 HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
    K032233 MEDLEY PCA MODULE, MODEL 8120
    K031566 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
    K030661 STRYKER PAINPUMP2
    K020421 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    K020418 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    K022203 ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
    K013822 MICROJET CRONO PCA
    K002739 INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
    K002434 PALM PUMP
    K990312 AVIA PAIN MEDICATION DELIVERY SYSTEM
    K982839 CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
    K943310 MODEL 6100 AMBULATORY INFUSION SYSTEM
    K934551 VERIFUSE AMBULATORY PUMP
    K920637 PRIME PCA AND PCA/CONTINUOUS SYSTEMS
    K915270 PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
    K921994 BARD PCA II PUMP WITH PROGRAM CARTRIDGES
    K915063 IVAC PC ANIFUSER
    K914502 BARD PCA II PUMP WITH PROGRAM CARTRIDGES
    K910257 BAXA PCA INFUSOR
    K911791 CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.