BEUDAMED
    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: FYC FDA class 2

    Gown, Isolation, Surgical

    General, Plastic Surgery

    View full classification →

    An isolation surgical gown is a specialized garment providing a fluid-resistant barrier worn by surgical personnel in cases requiring enhanced isolation precautions, protecting both patient and clinical staff from cross-contamination. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYC, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
    Copioumed Chemotherapy Isolation Gown
    Disposable Isolation Gown
    Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
    Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
    Paneffort AAMI Level 3 Isolation Gown
    CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
    AAMI4 Isolation Gown
    Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
    Surgical Isolation Cover Gown
    AAMI3 Isolation Gown
    Disposable Surgical Isolation Gown
    Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
    Plus Medical Isolation Gown Level 3
    Surgical isolation gown
    Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
    Protect X Level 3 Isolation Gown
    Disposable Surgical Gowns
    Isolation Gown AAMI Level 3
    ComfortGuard Surgical Isolation Gown
    Surgical Isolation Gown
    Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
    AMD Ritmed AssureWear VersaGown
    SURGICAL ISOLATION GOWN
    Medline Non-Surgical Isolation Gown-
    PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
    Cardinal Health Isolation Gown
    100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
    CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
    KENTRON'S ISOLATION GOWN
    IMPERVIOUS ISOLATION GOWN
    FAR-EAST BARRIER GOWNS
    NON-STERILE ISOLATION GOWN
    ISOLATION GOWN
    SURGICAL APPAREL
    NIOMED BARRIER GOWNS
    BARRIER GOWN, KOOL-GARD BACKLESS GOWN
    KOOL GARD SINGLES GOWN
    COVER GOWN
    DI ISOLATION GOWN
    BUSE STAFF PROTECTION GOWNS AND KITS
    OREX ISOLATION GOWN
    NON-STERILE ISOLATION GOWN
    TBC TRAUMA SUIT PROTECTIVE GOWN
    ISOLATION GOWNS
    POLY-MED DISPOSABLE PERSONAL PROTECTION KIT
    POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS
    DYNASTY IMPERVIOUS ISOLATION J-SUIT
    SURGEON'S GOWN
    DYNASTY ISOLATION GOWN

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump