Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1435](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1435) → DXG — Computer, Diagnostic, Pre-Programmed, Single-Function # DXG · Computer, Diagnostic, Pre-Programmed, Single-Function _Cardiovascular · 21 CFR 870.1435 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG ## Overview - **Product Code:** DXG - **Device Name:** Computer, Diagnostic, Pre-Programmed, Single-Function - **Regulation:** [21 CFR 870.1435](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1435) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 177) Showing 20 most recent of 177 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253092](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K253092.md) | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | Feb 13, 2026 | SESE | | [K251275](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K251275.md) | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | Sep 26, 2025 | SESE | | [K232048](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K232048.md) | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | Dec 20, 2023 | SESE | | [K212529](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K212529.md) | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | Nov 23, 2021 | SESE | | [K192169](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K192169.md) | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | Apr 30, 2020 | SESE | | [K193179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K193179.md) | EV1000 Clinical Platform | Edwards Lifesciences, LLC | Dec 17, 2019 | SESE | | [K190955](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K190955.md) | Hypotension Decision Assist | Directed Systems, Ltd. | Nov 27, 2019 | SESE | | [K181372](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K181372.md) | Argos | Retia Medical, LLC | Dec 13, 2018 | SESE | | [K172259](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K172259.md) | PulsioFlex Monitoring System | Pulsion Medical Systems SE | Jan 18, 2018 | SESE | | [K163334](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K163334.md) | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | Jun 5, 2017 | SESE | | [K152935](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K152935.md) | LiDCOunity Monitor | Lidco, Ltd. | Mar 17, 2016 | SESE | | [K134051](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K134051.md) | TRANSONIC ELSA SYSTEM | Transonic Systems, Inc. | Jan 29, 2015 | SESE | | [K134035](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K134035.md) | TRANSONIC HCM 103 SYSTEM | Transonic Systems, Inc. | Sep 17, 2014 | SESE | | [K140017](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K140017.md) | TRANSONIC HCM 102 SYSTEM | Transonic Systems, Inc. | Sep 16, 2014 | SESE | | [K132892](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K132892.md) | TEBCO-W | Bomed, Inc. | Aug 1, 2014 | SESE | | [K131892](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K131892.md) | EV1000 CLINICAL PLATFORM | Edwards Lifesciences, LLC | May 22, 2014 | SESE | | [K131588](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K131588.md) | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR | Edwards Lifesciences, LLC | May 22, 2014 | SESE | | [K132528](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K132528.md) | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | Jan 16, 2014 | SESE | | [K122400](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K122400.md) | CARDIOX FLOW DETECTION SYSTEM | Cardiox Corp. | Nov 5, 2013 | SESE | | [K131048](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K131048.md) | LIDCO CNAP MODULE | Lidco, Ltd. | Aug 28, 2013 | SESE | ## Top Applicants - Edwards Lifesciences, LLC — 10 clearances - Lidco, Ltd. — 7 clearances - Hewlett-Packard Co. — 6 clearances - Transonic Systems, Inc. — 5 clearances - Abbott Laboratories — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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