510(k) · Cleared
Recalled · Class II · 2019PulsioFlex Monitoring System
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 Jan 18, 2018 as substantially equivalent to K122121 (Pulsion Medical Systems SE, 2012) after a 175-day review. Its family tree reaches back 1 generation to 2012. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 18, 2018
- Review
- 175 days
- Class
- Class II
- Product code
- DXG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122121 (2012). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK122121 Pulsioflex Monitoring System with Picco ModulePulsion Medical Systems SE · 2012
- This deviceK172259 PulsioFlex Monitoring SystemPulsion Medical Systems SE · 2018
- Descendant · cites it directly · 1 of its ownK183521 CNAP MonitorCnsystems Medizintechnik GmbH · 2019
- Descendant · 2 generations on · 0 of its ownK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
- Descendant · cites it directly · 0 of its ownK192169 PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122121 | Pulsioflex Monitoring System with Picco Module | Pulsion Medical Systems SE | 2012 | — |
| 0 (this device) | K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | 2018 | — |
| +1 | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | — |
| +2 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | — |
| +1 | K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
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 |
|---|---|---|---|
| * | K122121 | Pulsioflex Monitoring System with Picco ModuleSummary page 4…computer. Classification: According to 21 CFR 870.1435 the device classification is Class II, Product code DXG. Predicate Device: K122121, PulsioFlex Monitoring System with PiCCO Module… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2019 | Class II | Z-2077-2019 | Software design | The monitor displays an error message . The error message states "internal error restart or service". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K183521 (Cnsystems Medizintechnik GmbH, 2019) has gone furthest, with 1 descendant of its own.
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. 2018, 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 determined…
Read the full statement (137 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.
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/K172259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172259: PulsioFlex Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172259
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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