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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.

    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.

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    Product Code: KDQ FDA class 2

    Bottle, Collection, Vacuum

    General Hospital

    View full classification →

    A vacuum collection bottle is a sealed container connected to a hospital suction system to collect aspirated fluids, secretions, or wound exudate from patients, used alongside vacuum regulators and suction tubing in clinical drainage applications. It is classified as an FDA Class 2 device, indicating moderate risk, and requires premarket clearance. Product code KDQ is regulated under 21 CFR 880.6740 in the General Hospital medical specialty. No additional special flags apply to this device.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    EXPRESS CHEST DRAIN
    MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
    OCEAN CHEST DRAIN
    ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
    PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
    ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
    MUCUS SPECIMEN TRAP
    ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
    PM9000 VAC TRAP
    THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
    ATRIUM 2000 CHEST DRAIN
    PLEUR-EVAC CHEST DRAINAGE SYSTEMS
    ATRIUM 2000, CHEST DRAIN
    PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
    THORA-KLEX CHEST DRAINAGE UNIT
    PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
    ELIMINATOR AIR FILTER
    PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
    MUCUS TRAP OR SUCTION TRAP
    URESIL THORACIC VENT
    T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
    FILTERED VACUUM SAFETY TRAP BOTTLE
    LM2000A SURGICAL SUCTION MONITOR
    COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
    BARD PARKER THORACIC VENT
    NIFA NON INVASIVE FLUTTER ASSEMBLY
    GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
    COMPACT 2000
    ABCO SUCTION CANISTER
    PLURA-GARD CHEST DRAINAGE SYSTEM
    THORAX-KLEX CHEST DRAINAGE UNIT
    THORACIC DRAINAGE SET #55-DB2-G
    PLEURAL DRAINAGE SYSTEM #PDS-4300
    VACUUM SUCTION FILTER
    MODIFIED THORACENTESIS CATHETER
    CALIBRATED BREATHING SYSTEM COLLECTION
    VAC-RITE SUNCTION COLLECTION
    SUCTION COLLECTION BOTTLE, DISPOSABLE
    ELECTRO-SUCTION UNIT
    ARGYLE SUCTION CANISTER W/DISP. LINER
    THORA-DRAIN III PLASTIC DRAINAGE SYSTEM
    SNYDER HEMOVAC CHEST DRAINAGE SOLUTION
    CONPHAR SILICONE DRAINS-STERILE
    SEP-T-VAC SUCTION CANNISTER W/ TUBING
    TUBES, LUKENS, TOMAS
    SUCTION CANISTER
    VAC-RITE
    AQUA-SEAL

    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
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