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: JOH FDA class 2

    Tube Tracheostomy And Tube Cuff

    Anesthesiology

    View full classification →

    The Tube Tracheostomy and Tube Cuff is an airway management device used to maintain a patent airway through a surgically created opening in the trachea (tracheostomy), with an inflatable cuff to seal the airway and prevent aspiration in patients requiring long-term ventilatory support or airway protection. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOH and is regulated under 21 CFR 868.5800, within the Anesthesiology medical specialty. This device is classified as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
    TRACOE vario
    Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
    Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
    Shiley Neonatal/Pediatric Tracheostomy Tube
    BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
    Weinmann Tracheostomy Exchange Set
    TRACOE silcosoft Tracheostomy Tube
    Portex Blue Line Ultra Paediatric Tracheosomy Tube
    ProTrach Dualcare
    Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
    Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
    Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
    H&H EMERGENCY CRICOTHYROTOMY KIT
    RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
    CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
    SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
    RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
    FAHL TRACHEOSTOMY TUBES (MULTIPLE)
    SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
    SHIKANI SPEAKING VALVE
    CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
    BIVONA TRACHEOSTOMY TUBES
    BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
    PROVOX MICRON HME
    CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
    SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
    TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
    MARPAC MESSENGER MODEL #501
    CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
    PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
    PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
    SHILEY FLEXTRA TRACHEOSTOMY TUBE
    PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
    RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
    PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
    TRACH VOX
    PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
    THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
    SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
    STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
    PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
    DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
    SHIKANI-FRENCH SPEAKING VALVE
    RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
    PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
    IRRIGATION BOTTLE
    RUSCH TRACHEOFIX-SET
    FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
    RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE

    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