DXG · Computer, Diagnostic, Pre-Programmed, Single-Function
Cardiovascular · 21 CFR 870.1435 · Class 2
Overview
| Product Code | DXG |
|---|---|
| Device Name | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Regulation | 21 CFR 870.1435 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | Feb 13, 2026 | SESE |
| K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | Sep 26, 2025 | SESE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMS | Icu Medical | Dec 20, 2023 | SESE |
| K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | Nov 23, 2021 | SESE |
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | Apr 30, 2020 | SESE |
| K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | Dec 17, 2019 | SESE |
| K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | Nov 27, 2019 | SESE |
| K181372 | Argos | Retia Medical, LLC | Dec 13, 2018 | SESE |
| K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | Jan 18, 2018 | SESE |
| K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | Jun 5, 2017 | SESE |
| K152935 | LiDCOunity Monitor | Lidco, Ltd. | Mar 17, 2016 | SESE |
| K134051 | TRANSONIC ELSA SYSTEM | Transonic Systems, Inc. | Jan 29, 2015 | SESE |
| K134035 | TRANSONIC HCM 103 SYSTEM | Transonic Systems, Inc. | Sep 17, 2014 | SESE |
| K140017 | TRANSONIC HCM 102 SYSTEM | Transonic Systems, Inc. | Sep 16, 2014 | SESE |
| K132892 | TEBCO-W | Bomed, Inc. | Aug 1, 2014 | SESE |
| K131892 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences, LLC | May 22, 2014 | SESE |
| K131588 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR | Edwards Lifesciences, LLC | May 22, 2014 | SESE |
| K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | Jan 16, 2014 | SESE |
| K122400 | CARDIOX FLOW DETECTION SYSTEM | Cardiox Corp. | Nov 5, 2013 | SESE |
| K131048 | 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
