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: DTN FDA class 2

    Reservoir, Blood, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    The Cardiopulmonary Bypass Blood Reservoir is a cardiovascular device that temporarily stores venous blood collected from the patient during extracorporeal bypass, allowing the perfusionist to manage blood volume and prevent air entrainment in the circuit 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 DTN and it is regulated under 21 CFR 870.4400 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Quantum Perfusion Hybrid System
    MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL
    BMR 1900 PHISIO
    Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
    INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
    Capiox Advance Hardshell Reservoir
    Intersept Filtered Cardiotomy Reservoir
    NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
    AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
    INITARY BETTER BLADDER-PEDIATRIC
    VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
    AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
    XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
    AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
    NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
    XRES BLOOD COLLECTION RESERVOIR
    VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
    VENOUS HARDSHELL CARDIOTOMY RESERVIORS
    SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
    MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
    MEDOS HILITE RESERVOIR, MODEL: 4030
    GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
    GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
    JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
    3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
    MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
    VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
    CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
    GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
    V-BAG WITH GBS COATING
    SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
    CAPIOX FLEXIBLE VENOUS RESERVOIR
    CAPIOX CARDIOTOMY RESERVOIR
    MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
    SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
    MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
    HEMOBAG, MODEL HBBSD2000
    GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
    SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
    MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
    SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
    TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
    CAPIOX RX HARDSHELL RESERVOIR
    THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
    VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
    TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
    MODEL 4815 ADAPTER
    CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
    THE V-BAG

    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