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: DSF FDA class 1

    Recorder, Paper Chart

    Cardiovascular

    View full classification →

    The Paper Chart Recorder is a cardiovascular documentation device used to produce a permanent hard-copy record of physiological waveforms such as ECG, blood pressure, or other signals on a continuous roll or strip of paper. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DSF and it is regulated under 21 CFR 870.2810 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EDENTEC DIGITAL CHARTER MODEL 3710
    DASH IV
    MODEL 556 MONITOR
    GRI LASERGRAPH(TM) ECG PAPER
    COLORADO COLOR IMAGING RECORDER
    GABRIEL MEDICAL CLS THERMAL RECORDER
    TYPE 9541 RECORDER, PAPER CHART
    WR3500 AND WR3600 SERIES RECORDERS
    MT96000 PAPER CHART RECORDER
    PAQ10 PAPER CHART RECORDER
    EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
    CARDIOCAP(TM) DR-104 REPORTER
    DUAL GRAPH (TM) RECORDER-MONITOR
    FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
    A10 ULTRASCOPE RECORDER
    CORTRONIC SCR1000
    EDENTEC MODEL 4700 SCANNER
    EDENTRACE MULTI-CHARTER MODEL 3700
    WS 800R THERMAL ARRAY RECORDER
    LIFESTAT 1600 PRINTER
    DATALOGGER CHART RECORDER
    VSM(R) R2 PAPER CHART RECORDER
    MODEL 78576A PAPER CHART RECORDER
    MODEL 192 PRINTER
    FIBRE OPTIC STRIP CHART RECORDER
    IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM
    SIREDOC 60 AND SIREDOC 220
    DR-2C (MODIFICATION)
    MODEL 535 NEO-TRAK RECORDER
    LONG TERM RECORDER RAG 1200
    SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000
    FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
    SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
    OHMEDA MODEL 0001/0003 RECORDER
    RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE
    NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
    SIREDOC, PAPER CHART RECORDER
    THERMAL GRAYSCALE RF-100
    2-CHANNEL RECORDER
    I-CHANNEL RECORDER
    NARCOTRACE 40 - NT40
    MONITORING SYSTEM AS100-AS115 RECORD
    PHOENIX 60/60 PROCESSOR MODULE
    MEDICAL ELECTRONICS-PRINTER CLOCK
    VENTURE II MONITORING SYSTEM
    DUAL CHANNEL RECORDER #78574A
    MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
    MINGOCARD 7 & MINGOPHONE 7
    MODEL 525 NEO-TRAK NEONATAL RECORDER
    CENTURION CHART RECORDER

    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