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: DTM FDA class 2

    Filter, Blood, Cardiopulmonary Bypass, Arterial Line

    Cardiovascular

    View full classification →

    The Arterial Line Blood Filter for Cardiopulmonary Bypass is a life-sustaining cardiovascular device placed in the arterial return line of a bypass circuit to remove air, particulate debris, and microemboli from blood before it is returned to the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTM and it is regulated under 21 CFR 870.4260 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    KIDS Arterial Filters
    MICRO Arterial Filters
    OCS Heart Leukocyte Depleting Filter
    AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
    AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
    TERUMO PALL AL20X ARTERIAL FILTER
    D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
    AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
    AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
    QUART ARTERIAL FILTER WITH SOFTLINE COATING
    AF 840 PH.I.S.I.O. ARTERIAL FILTER
    TERUMO PALL AL3X ARTERIAL FILTER
    TERUMO PALL AL6X ARTERIAL FILTER
    GISH ARTERIAL FILTER WITH HA COATING
    QUART ARTERIAL FILTER WITH BIOLINE COATING
    D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
    AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
    D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
    MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
    QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
    D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
    CAPIOX AF125X ARTERIAL FILTER
    D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER
    D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
    DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
    D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
    AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
    EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
    TERUMO AL8X ARTERIAL FILTER WITH X-COATING
    DBT, DYNAMIC BUBBLE TRAP
    GISH ARTERIAL FILTER WITH GBS COATING
    EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
    AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
    CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
    DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
    CAPIOX ARTERIAL FILTER
    QUART ARTERIAL FILTER, MODEL HBF 140
    AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
    MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
    AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
    COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
    PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
    DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
    AFFINITY ARTERIAL BLOOD FILTER
    DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
    CAPIOX ARTERIAL FILTER
    DIDECO PEDIATRIC ARTERIAL FILTERS
    MEDTRONIC ARTERIAL FILTER
    GISH ARTERIAL FILTER
    SHILEY PERFUSION TUBING 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.

    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