510(k) · Cleared
ClearedPulsioFlex Monitoring System with ProAQT Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsion Medical Systems SE · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Apr 30, 2020 as substantially equivalent to K172259 (Pulsion Medical Systems SE, 2018) after a 265-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Apr 30, 2020
- Review
- 265 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K122121 (2012). No later device cites it as a predicate yet.
- Root · 2 generations backK122121 Pulsioflex Monitoring System with Picco ModulePulsion Medical Systems SE · 2012
- 1 generation backK172259 PulsioFlex Monitoring SystemPulsion Medical Systems SE · 2018 · Recalled
- This deviceK192169 PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE · 2020
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172259 | PulsioFlex Monitoring SystemSummary page 4…computer. Classification According to 21 CFR 870.1435 the device classification is Class II, Product code DXG. Predicate Device K172259, PulsioFlex Monitoring System… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K172259.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient’s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. - With the PiCCO Module cardiac output is…
Read the full statement (157 words)
The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient’s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed.
- With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
- With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
- With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring.
The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192169: PulsioFlex Monitoring System with ProAQT Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026