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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: FMK FDA class 2

    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    General, Plastic Surgery

    View full classification →

    A single-use blood lancet with an integral sharps injury prevention feature is a disposable device consisting of a single-use blade on a non-reusable base, used to puncture the skin to obtain a small blood sample for diagnostic purposes. The integral sharps injury prevention feature renders the device inoperable after a single use, preventing needlestick injuries. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMK, regulated under 21 CFR 878.4850 in the General and Plastic Surgery specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    safety lancet
    Heel Incision Safety Lancet (SteriHeel 2)
    Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
    LetsGetChecked Impress
    gentleheel® Adult Incision Device
    Safety Lancet
    Safety Lancet
    MedtFine Safety Lancet
    Medifun Safety Lancet ( MSL1 series)
    Safety Lancet (XXXV)
    Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
    RedDrop ONE (One)
    NanoDrop Lancet
    Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
    Accu-Chek Safe-T-Pro Plus Lancing Device
    Accu-Chek Safe-T-Pro Uno Lancing Device
    Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
    TAP Lancet
    Tenderfoot
    babyLance Safety Heelstick (BLM, BLN, BLP)
    NeatNick Heel Safety Lancet
    Safety Lancet
    Safety Lancet
    Disposable Safety Lancets
    BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets
    Disposable Safety Lancet
    Disposable Sterile Lancet
    Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
    OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
    Disposable Safety Lancet
    Unistik® Pro
    SafetiCET Safety Lancet
    Disposable Safety Lancets
    Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
    Safety Lancet
    SurgiLance® Safety Lancet
    Lancet
    Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
    SafetiHeel, MediHeel, Novaplus
    Tasso+
    Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets
    DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
    Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
    Promisemed Heel Blood Lancet
    Accu-Chek Safe-T-Pro Plus Lancing Device
    Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
    gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
    Heel Stick Safety Lancet (HHZ-II, HHZ-III)
    Accu-Chek Safe-T-Pro Uno Lancing Device
    Heel Incision Safety Lancet

    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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