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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: CHL FDA class 2

    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

    Clinical Chemistry

    View full classification →

    The Electrode Measurement, Blood-Gases (pCO2, pO2) and Blood pH test system (product code CHL) is an in-vitro diagnostic device used in clinical chemistry to measure partial pressures of carbon dioxide and oxygen as well as blood pH using electrochemical electrodes, providing critical information for respiratory and metabolic status assessment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1120 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    i-STAT CG4+ cartridge with the i-STAT 1 System
    ABL90 FLEX PLUS System
    i-STAT CG8+ cartridge with the i-STAT 1 System
    Stat Profile Prime Plus Analyzer System
    i-STAT G3+ cartridge with the i-STAT 1 System
    GEM Premier 7000 with IQM3
    EasyStat 300
    GEM Premier 5000
    OPTI® B-Lac Cassette
    epoc Blood Analysis System
    i-STAT CG4+ Cartridge with the i-STAT 1 System
    RAPIDPoint 500e Blood Gas System
    Stat Profile Prime Plus Analyzer System
    Stat Profile Prime Plus Analyzer System
    GEM Premier 5000
    GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
    ABL90 FLEX PLUS
    EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
    Stat Profile Prime ABG Analyzer System
    ABL80 FLEX CO-OX with AQURE connectivity
    ABL800 FLEX with AQURE connectivity
    STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
    Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
    NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
    GEM PREMIER 4000
    ABL90 FLEX ANALYZER
    OPTI CCA-TS2
    ABL90 FLEX
    ABL90 FLEX
    MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
    ABL90 FLEX
    ABL90 FLEX
    COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
    ABL90 FLEX
    NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
    ABL90
    ABL835 FLEX ANALYZER WITH PLEURAL PH
    OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
    ABL837 FLEX ANALYZER
    ABL 80 CO-OX SYSTEM
    EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
    GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
    ABL80 FLEX ANALYZER
    ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
    OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
    ABL800 FLEX
    BAYER RAPIDLAB 1200 SYSTEM
    STAT PROFILE PHOX PLUS L ANALYZER
    STAT PROFILE CRITICAL CARE XPRESS ANALYZER
    STAT PROFILE PHOX PLUS C ANALYZER

    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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