BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BAXA PCA INFUSOR

    K Number: K910257 · Decision Nov 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    16
    Review Days
    289

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BAXA PCA INFUSOR
    K Number
    K910257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Baxa Corp., Sub. of Cook Group, Inc.
    Date Received
    January 22, 1991
    Decision Date
    November 7, 1991
    Product Code
    MEA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MEA Pump, Infusion, Pca

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MEA), ordered by most recent decision date.

    ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital

    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)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LifeCare PCA Infusion System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Baxa Corp., Sub. of Cook Group, Inc.

    K Number Device Name
    K903159 VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
    K904225 KWIKMIX
    K900585 TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
    K873875 BAXA EXACTA-MED PHARMACY PUMP
    K872743 BAXA TUBING SETS (FOR PHARMACY PUMP)
    K844904 CYTOSAFE NEEDLE
    K832332 VENTED I.V. TRANSFER NEEDLE
    K832312 I.V. TRANSFER NEEDLE
    K832347 TWOFER NEEDLE
    K832254 BAXA ADDISEAL
    Search all 16 clearances from Baxa Corp., Sub. of Cook Group, Inc. →