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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: DXQ FDA class 2

    Blood Pressure Cuff

    Cardiovascular

    View full classification →

    The Blood Pressure Cuff is a cardiovascular device consisting of an inflatable bladder housed within an elastic sleeve, used together with a pressure gauge to determine a subject's arterial blood pressure. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance before marketing. The product code is DXQ and the applicable regulation is 21 CFR 870.1120, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
    NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
    Disposable Neonatal NIBP Cuff (U1681S-C51N)
    Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
    AViTA Arm Type Blood Pressure Monitor Cuff
    Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
    Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
    Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
    Reusable Blood Pressure Cuff
    Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)
    NIBPCuff
    Aneroid Sphygmomanometer
    ONE-CUF
    Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
    Disposable Blood Pressure Cuff
    Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
    WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
    Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
    Reusable NIBP Cuff
    Aneroid Sphygmomanometer
    Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
    Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
    Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
    Disposable NIBP Cuff
    Reusable NIBP Cuff
    Aneroid Type Blood Pressure Kit
    RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
    Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
    Reusable NIBP Cuff
    Med-link Reusable Blood Pressure Cuff
    ANEROID SPHYGMOMANOMETER
    Accutension Smartphone Auscultatory Blood
    Reusable Blood Pressure Cuff
    Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
    Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
    Medline Singe Patient Use Blood Pressure Cuff
    Cogent Hemodynamic Monitoring System
    Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
    Bpump Blood Pressure Cuff
    Reusable Blood Pressure Cuff
    Disposable Blood Pressure Cuff
    ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
    Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
    Aneroid Sphygmomanometer
    Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
    Minhua Disposable Blood Pressure Cuff
    Fast Sphyg by Koven
    Disposable Blood Pressure Cuff Guard
    SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
    GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF

    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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