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: NGT FDA class 2

    Saline, Vascular Access Flush

    General Hospital

    View full classification →

    The Saline, Vascular Access Flush (product code NGT) is a general hospital device consisting of saline solution used to flush intravascular catheters to maintain patency and prevent clot formation, as described in its definition. It is classified as an FDA Class 2 device within the General Hospital specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    Praxiject™ SP 0.9% NaCl
    Flush Syringe (Prefilled 0.9% normal saline solution)
    Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
    TK Pre-Filled Normal Saline Flush Syringe
    Pre-Filled Normal Saline Flush Syringe
    0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
    Praxiject™ 0.9% NaCl
    Pentaflush
    Pre-filled Syringe with Saline
    AMSafe Pre-Filled Normal Saline Flush Syringe
    0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
    Praxiject 0.9% NaCl
    0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
    AMSafe(R) Pre-Filled Normal Saline Flush Syringe
    0.9% Sodium Chloride Injection, USP
    Praxiject 0.9% NaCl
    0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
    0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
    Normal Saline Flush
    0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
    0.9% SODIUM CHLORIDE FLUSH SYRINGE
    0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
    0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
    MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
    IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
    0.9% SODIUM CHLORIDE FLISH SYRINGE
    AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
    AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
    FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
    MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
    STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
    STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
    KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
    0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
    MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
    MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
    MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
    MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    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