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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: DQA FDA class 2

    Oximeter

    Cardiovascular

    View full classification →

    The Oximeter is a non-invasive diagnostic device that measures blood oxygen saturation by detecting the differential absorption of light by oxygenated and deoxygenated hemoglobin, widely used in clinical monitoring of patients' respiratory and cardiovascular status. It is a Class 2 device requiring 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. The product code is DQA, regulated under 21 CFR 870.2700, within the Cardiovascular medical specialty. No special regulatory flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
    Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
    Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
    Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
    AViTA Pulse Oximeter (SP61)
    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
    Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
    Spo2 Sensor CSS032D
    Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
    Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
    Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)
    Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
    Pulse Oximeter
    Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
    Avidhrt Sense SpO2
    Pulse Oximeter ( PO2, PO2A, PO2B)
    Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
    Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
    AViTA Pulse Oximeter (SP62B)
    Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
    Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
    Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
    Evie Med Ring
    Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
    Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
    Belun Ring BLR-200 (BLR-200)
    Pulse Oximeter (WS20A)
    OxiWear
    Mecun SpO2 sensor
    Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
    Pulse Oximeter (MD300C228)
    ANNE Limb
    AViTA Pulse Oximeter
    Sempulse Halo Vital Signs Monitor
    Vyvo
    Pulse Oximeter(Model OHT60,OXH78)
    Pediarity™
    Masimo Stork
    Wrist Pulse Oximeter
    Finger Clip Pulse Oximeter
    Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
    circul™ pro Ring
    Pulse Oximeter
    Pulse Oximeter
    BabySat 3
    Finger Pulse Oximeter, Model: X1906P
    Masimo Rad-G with Temperature
    Pulse Oximeter
    Handheld Pulse Oximeter
    Biobeat Platform-2 and BB-613WP Patch

    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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