Hypotension Decision Assist
FDA 510(k) K190955 · Directed Systems, Ltd.
510(k) numberK190955
Submission
- Device name
- Hypotension Decision Assist
- Applicant
- Directed Systems, Ltd.
Cambridge, GB - Received
- April 11, 2019
- Decision date
- November 27, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
Other 510(k)s with product code DXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0)DXG · Traditional | Retia Medical Systems, Inc. | 02/13/2026SE |
| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | Icu Medical | 12/20/2023SE |
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | Directed Systems, Ltd. | 11/23/2021SE |
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | Pulsion Medical Systems SE | 04/30/2020SE |
| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
| K152935 | LiDCOunity MonitorDXG · Traditional | Lidco, Ltd. | 03/17/2016SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | 11/23/2021SE |
Questions and answers
When was Hypotension Decision Assist cleared by the FDA?
Hypotension Decision Assist (K190955) received a 510(k) decision of Substantially Equivalent on November 27, 2019, 230 days after the submission was received.
What is the product code of K190955?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.