Cogent Hemodynamic Monitoring System; Cogent HMS
FDA 510(k) K232048 · Icu Medical
510(k) numberK232048
Submission
- Device name
- Cogent Hemodynamic Monitoring System; Cogent HMS
- Applicant
- Icu Medical
San Clemente, CA, US - Received
- July 10, 2023
- Decision date
- December 20, 2023
- 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
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| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
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| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K190955 | Hypotension Decision AssistDXG · Traditional | Directed Systems, Ltd. | 11/27/2019SE |
| 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 |
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Questions and answers
When was Cogent Hemodynamic Monitoring System; Cogent HMS cleared by the FDA?
Cogent Hemodynamic Monitoring System; Cogent HMS (K232048) received a 510(k) decision of Substantially Equivalent on December 20, 2023, 163 days after the submission was received.
What is the product code of K232048?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.