Pulsioflex
FDA 510(k) K112448 · Pulsion Medical Systems, Inc.
510(k) numberK112448
Submission
- Device name
- Pulsioflex
- Applicant
- Pulsion Medical Systems, Inc.
Westbrook, CT, US - Received
- August 25, 2011
- Decision date
- September 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | 04/30/2020SE |
| K171620 | PiCCO CatheterKRB · Traditional | 02/21/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | 01/18/2018SE |
| K122121 | Pulsioflex Monitoring System with Picco ModuleDXG · Special | 08/02/2012SE |
| K091786 | Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30…DXG · Traditional | 06/18/2010SE |
| K072735 | Pulsion PICCO-2, Model 8500DXG · Special | 10/18/2007SE |
| K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesKRB · Special | 09/19/2007SE |
| K060898 | Pulsion Picco Plus, Model 8100DXG · Traditional | 07/25/2006SE |
| K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046KRB · Traditional | 05/23/2002SE |
| K001762 | Pulsion Continuous Pulse Contour Cardiac Output (Picco) SystemDXG · Traditional | 06/13/2000SE |
Questions and answers
When was Pulsioflex cleared by the FDA?
Pulsioflex (K112448) received a 510(k) decision of Substantially Equivalent on September 22, 2011, 28 days after the submission was received.
What is the product code of K112448?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.