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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: DXN FDA class 2

    System, Measurement, Blood-Pressure, Non-Invasive

    Cardiovascular

    View full classification →

    The Non-Invasive Blood Pressure Measurement System is a cardiovascular device used to measure arterial blood pressure without penetrating the skin, typically using an external cuff and pressure transducer. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance prior to marketing. The product code is DXN and the applicable regulation is 21 CFR 870.1130, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    G0 Blood Pressure Monitoring System (G0)
    Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
    Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
    Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
    Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
    Globalcare Blood Pressure Monitor (GUS610)
    KOROT Blood Pressure Monitor (KOROT P3 Accurate)
    Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
    Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
    Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
    Electronic Blood Pressure Monitor
    Accurate Mini Non-invasive blood pressure monitor (AMB-001)
    Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
    Wrist Blood Pressure Monitor (OHMS11, OHMS12)
    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
    BB-613-BPM
    Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
    Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
    Arm Blood Pressure Monitor (model: BPM-A7VL)
    Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
    Arm Type Blood Pressure Monitor (BPM82)
    Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
    Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
    Blood Pressure Monitor (TMB-2092-G)
    Upper Arm Electronic Blood Pressure Monitor
    Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)
    Blood Pressure Monitor (BBZ32-AA01)
    Blood Pressure Monitor (TMB-2296-BT)
    Blood Pressure Monitor (TMB-2287-B)
    Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
    Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
    Blood Pressure Monitor
    Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
    Arm-type Fully Automatic Digital Blood Pressure Monitor
    Pursuant Health Kiosk (G1.D5)
    Blood Pressure Monitor
    Digital Blood Pressure Monitor (Model: YB-800)
    Wrist Blood Pressure Monitor
    SimpleSense-BP, SimpleSense-BP Software Application
    Electronic Blood Pressure Monitor
    Electronic Blood Pressure Monitor, model: HTD6602US
    Digital Blood Pressure Monitor
    Blood Pressure Monitor
    Blood pressure monitor
    Digital Blood Pressure Monitor (Arm Type)
    Electronic Blood Pressure Monitor
    Acumen IQ finger cuff
    Arm Blood Pressure Monitor
    Boppli Infant Blood Pressure Monitor
    Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)

    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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