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    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: PIF FDA class 2

    Gastrointestinal Tubes With Enteral Specific Connectors

    Gastroenterology, Urology

    View full classification →

    Gastrointestinal Tubes with Enteral Specific Connectors are feeding tubes designed to facilitate enteral-specific connections, incorporating connectors compliant with enteral feeding standards to reduce the risk of misconnection errors with other medical tubing systems. They are FDA Class 2 devices regulated under 21 CFR 876.5980, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) specialty. The product code is PIF. These devices are not implants and are not life-sustaining.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    Enteral Drainage System, Enteral Medicine straw
    Extension Feeding Set with ENFit™ Connectors
    Disposable Enteral Feeding Sets
    Mobility+ Enteral Feeding System OTC
    ENFit to ENFit Extension Sets
    Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
    Feeding Tube
    EnteraLoc Flow
    Mobility+ Enteral Feeding System
    Nasogastric Feeding Tubes - ENFit Port - PVC
    Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
    Entuit PEG, Entuit PEGJ
    Enteral Feeding Set
    Pediatric Nasogastric Feeding Tubes - Single ENFit Port
    Enteral Extension Sets
    EnteraLoc Flow
    Gabriel 3 Way EnFit Valve
    Nutricare Clear-ISOSAF Nasogastric Feeding Tube
    Vesco Medical Extension Feeding Set
    BD Univia RightFit Enteral Extension Sets and Transitional Adapters
    Medline Quick Switch Valve with ENFit Connector
    Gabriel Feeding Tube with Balloon, and EnFit Connector
    Salem Sump Dual Lumen Stomach Tube with ENFit Connection
    Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
    U Deliver Bolink ENFit Enteral Feeding Sets
    Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
    ENConnect 40 mm Screw Cap to ENPlus Adapter
    Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
    CONOD Enteral Feeding Sets
    Vesco Medical Nasoenteric Feeding Tubes
    U Deliver Bolink ENFit Enteral Feeding Sets
    Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
    Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
    Edi Catheter ENFit
    Medline ENFit Syringe
    EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
    NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
    Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
    Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
    EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
    Medline Enteral Feeding Sets
    Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
    Mini ONE Enteral Extension Set
    EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
    Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
    BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
    FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
    AQUARIUS NASAL FEEDING TUBE
    COMPAT ENTERAL DELIVERY PUMP SETS

    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.

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