BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

    K Number: K243468 · Decision Jul 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    22
    Review Days
    236

    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
    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
    K Number
    K243468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Joytech Healthcare Co. , Ltd.
    Date Received
    November 8, 2024
    Decision Date
    July 2, 2025
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

    Similar 510(k) Clearances

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

    FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    eRapid with eTrack System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mesh Nebulizer (H6)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Portable mesh nebulizer (JM821)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HeroTracker Sense

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AdheResp Smart Breath-actuated Mesh Nebulizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Joytech Healthcare Co. , Ltd.

    K Number Device Name
    K252501 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
    K252685 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
    K250548 Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
    K241431 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
    K241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
    K231303 Arm-type Fully Automatic Digital Blood Pressure Monitor
    K230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K213189 Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K200649 Arm-Type Fully Automatic Digital Blood Pressure Monitor
    Search all 22 clearances from Joytech Healthcare Co. , Ltd. →