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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: LRO FDA class 2

    General Surgery Tray

    General, Plastic Surgery

    View full classification →

    The General Surgery Tray is a prepackaged, sterile convenience kit containing assorted instruments and supplies used during general surgical procedures, assembled to streamline the preparation of the surgical field. This product code was established in accordance with the May 20, 1997 FDA guidance on convenience kits interim regulatory guidance, which outlines requirements for devices packaged together. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRO, regulated under 21 CFR 878.4370, within the General and Plastic Surgery medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Medline General Surgery Tray
    Medline Cardiovascular Procedure Kit
    SURGICAL DRAPE KIT - D.I.R.R.A. SRL
    QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
    AMSINO TRACHEOSTOMY CARE TRAY
    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
    OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
    OPPORTUNITY INC. GENERAL PURPOSE TRAY
    NEUROLOGICAL OR CRANI TRAYS (PACKS)
    PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
    RUNYON LARGE VOLUME PARACENTESIS KIT
    O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
    BASIC BIOPSY TRAY. DISPOSABLE, STERILE
    DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
    SKIN SCRUB TRAY
    SUCTION CATHETER TRAY PRODUCT NO. 900277
    PROD. NO. 02-031 - LACERATION TRAY
    MEDLINE RADIOLOGY-DIAGNOSTIC KITS
    PARACENTESIS TRAYS
    HOSPITAL LAUNDRY SERVICES SURGICAL PACKS
    JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
    RADIOLOGY PACKS
    GENERAL AND PLASTIC SURGERY PACKS
    WOUND CLOSURE/LACERATION TRAY
    SINGLE USE INSTRUMENT TRAY
    NEEDLE/CANNULA
    DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT
    SHAVE PREP KIT
    PARACENTESIS NEEDLES/CANNULAS
    CHIBA STYLE BIOPSY NEEDLE
    BONE MARROW BIOPSY TRAY
    JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT
    STERILE DESIGN
    INSTRUMENT TRAY
    CENTRAL LINE TRAY
    DRESSING CHANGE TRAY
    IRRIGATION TRAY
    MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
    ACU-SUTURE KIT
    PATIENT PREOPERATIVE PREP TRAY, SINGLE USE
    STERILE DRESSING CHANGE TRAY
    O.R. BASIN SET TRAY
    E-Z PREP(R) TRAY WITH HIBICLENS(R)
    CARAPACE STILLWATER BOWL SET
    CARAPACE PACKING GAUZE TRAYS
    STERILE LACERATION & DEBRIDEMENT TRAYS
    STERILE TRACHEOSTOMY TRAY
    CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
    VARIOUS KITS AND TRAYS
    CARAPACE STERILE GAUZE TRAYS

    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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