DXG — Computer, Diagnostic, Pre-Programmed, Single-Function Class II
FDA product code DXG covers "Computer, Diagnostic, Pre-Programmed, Single-Function", a Class II medical device regulated under 21 CFR 870.1435. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXG
- Device Class
- Class II
- Regulation Number
- 870.1435
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253092 | retia medical systems | Argos Infinity (Rev. 1.0) | February 13, 2026 |
| K251275 | caretaker medical | VitalStream ART Connect; VitalStream-Hemo | September 26, 2025 |
| K232048 | icu medical | Cogent Hemodynamic Monitoring System; Cogent HMS | December 20, 2023 |
| K212529 | directed systems | Hypotension Decision Assist Model HDA-OR2 | November 23, 2021 |
| K192169 | pulsion medical systems se | PulsioFlex Monitoring System with ProAQT Sensor | April 30, 2020 |
| K193179 | edwards lifesciences | EV1000 Clinical Platform | December 17, 2019 |
| K190955 | directed systems | Hypotension Decision Assist | November 27, 2019 |
| K181372 | retia medical | Argos | December 13, 2018 |
| K172259 | pulsion medical systems se | PulsioFlex Monitoring System | January 18, 2018 |
| K163334 | lidco | LiDCOunity v2 Hemodynamic Monitor | June 5, 2017 |
| K152935 | lidco | LiDCOunity Monitor | March 17, 2016 |
| K134051 | transonic systems | TRANSONIC ELSA SYSTEM | January 29, 2015 |
| K134035 | transonic systems | TRANSONIC HCM 103 SYSTEM | September 17, 2014 |
| K140017 | transonic systems | TRANSONIC HCM 102 SYSTEM | September 16, 2014 |
| K132892 | bomed | TEBCO-W | August 1, 2014 |
| K131892 | edwards lifesciences | EV1000 CLINICAL PLATFORM | May 22, 2014 |
| K131588 | edwards lifesciences | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY | May 22, 2014 |
| K132528 | ge healthcare finland | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | January 16, 2014 |
| K122400 | cardiox | CARDIOX FLOW DETECTION SYSTEM | November 5, 2013 |
| K131048 | lidco | LIDCO CNAP MODULE | August 28, 2013 |