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

    NxtGen Infant Transport Incubator

    K Number: K220742 · Decision Jul 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    8
    Review Days
    123

    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
    NxtGen Infant Transport Incubator
    K Number
    K220742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biomedical
    Date Received
    March 14, 2022
    Decision Date
    July 15, 2022
    Product Code
    FPL
    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
    FPL Incubator, Neonatal Transport

    Similar 510(k) Clearances

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

    SREE MRI Transport Incubator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GLOBE-TROTTER GT5400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATOM TRANSCAPSULE V-707

    FDA 510(k)
    FDA Class 2 ·General Hospital

    A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

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

    Other Clearances by International Biomedical

    K Number Device Name
    K221154 Infant Heel WarmerTM; Heel Snuggler®
    K221653 InfaTherm Disposable Infant Warming Mattress
    K193481 AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
    K182956 Puffin Lite Infant Resuscitation System
    K173516 NuBorne Infant Warmer
    K160238 Airborne Phototherapy Light
    K140707 LIFEBORNE INFANT RESUSCITATOR