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.

    Let the assistant find your predicates

    Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples
    Product Code: JSK FDA class 1

    Supplement, Culture Media

    Microbiology

    View full classification →

    The Supplement, Culture Media is a microbiology diagnostic additive used to enrich or modify standard culture media by supplying growth factors, nutrients, or selective agents that improve the recovery, viability, or selectivity of the medium for specific microorganisms in clinical diagnostic applications. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSK and is regulated under 21 CFR 866.2450, within the Microbiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ATS NAC-PAC SET
    ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42
    HEMOGLOBIN POWDER
    PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
    GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
    GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
    PENICILLIN-STREPTOMYCIN-FUNGIZONE
    KWI (TM) G-CO/TWO
    ABBOTT CATION SUPPLEMENT SOLUTION
    SUPLEX & SUPLEX DILUENT
    CAMPYLOBACTER SUPPLEMENT-BLASER/WANG
    C.L.A.T.
    SUPPLEMENT FOR CULTURE MEDIUM
    YEAST DIALYSATE
    C.N.V.T.
    MUCOLYSE
    CAMPYLOBACTER SUPPLEMENT -SKIRROW
    LEGIONELLA BMPA SELECTIVE SUPPLE
    LEGIONELLA MWY SELECTIVE SUPPLEMENT
    PRESTON CAMPYLOBACTER SELECTIVE SUPP
    CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
    TINSDALE ENRICHMENT
    LACTOSE
    CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW
    CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER
    CAMPYLOBACTER SELECTIVE SUPPLE-BLASER
    MIDDLEBROOK ADC ENRICHMENT
    LEGIONELLA CYE AGAR BASE & BCYE SUPPL
    CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE
    GELRITE
    N-S ANAEROBE SUPPLEMENT
    G-N ANAEROBE SUPPLEMENT
    VCAT ANTIBIOTIC SUPPLEMENT
    YERSINIA SELECTIVE SUPPLEMENT
    LCAT ANTIBIOTIC SUPPLEMENT
    YEAST AUTOLYXATE SUPPLEMENT
    GELYSATE
    BIOSATE
    PHYTONE
    POLYPEPTONE PEPTONE
    THIOTONE PEPTONE
    LEGIONELLA, GROWTH & SELECTIVE, SUPP.
    VCNT ANTIBIOTIC SUPPLEMENT
    VCN SUPPLEMENT
    HUMAN BLOOD IN ALSEVER'S
    HEMOGLOBIN POWDER
    YEAST EXTRACT
    PANCREATIC HYDROLYSATE OF HEART MUSCLE
    VITOX
    PACT SUPPLEMENT

    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