510(k) · Cleared
ClearedPulsioflex Monitoring System with Picco Module
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 Aug 2, 2012 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 2, 2012
- Review
- 16 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK122121 Pulsioflex Monitoring System with Picco ModulePulsion Medical Systems SE · 2012
- Descendant · cites it directly · 3 of its ownK172259 PulsioFlex Monitoring SystemPulsion Medical Systems SE · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK183521 CNAP MonitorCnsystems Medizintechnik GmbH · 2019
- Descendant · 3 generations on · 0 of its ownK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK192169 PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE · 2020
Most influential descendants
Showing 4 of 4 · See all- K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE · 2018 · cites it directly3descendants
- K183521CNAP MonitorCnsystems Medizintechnik GmbH · 2019 · 2 generations on1descendant
- K223332Task Force CORECnsystems Medizintechnik GmbH · 2023 · 3 generations on0descendants
- K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122121 | Pulsioflex Monitoring System with Picco Module | Pulsion Medical Systems SE | 2012 | — |
| +1 | K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | 2018 | 1 |
| +2 | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | — |
| +3 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | — |
| +2 | K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172259 | PulsioFlex Monitoring System | 2018 | 3 |
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?
- Of its descendants, K172259 (Pulsion Medical Systems SE, 2018) has gone furthest, with 3 descendants 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. 2012, 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 PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour…
Read the full statement (131 words)
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122121: Pulsioflex Monitoring System with Picco Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122121
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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