510(k) · Cleared
ClearedPulsion Picco Plus, Model 8100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsion Medical Systems AG · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jul 25, 2006 after a 113-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK060898 Pulsion Picco Plus, Model 8100Pulsion Medical Systems AG · 2006
- Descendant · cites it directly · 0 of its ownK140017 Transonic HCM 102 SystemTransonic Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK132528 E-Picco Continuous Cardiac Output Module and AccessoriesGE Healthcare Finland Oy · 2014
- Descendant · cites it directly · 0 of its ownK073113 Infinity Picco Pod, Model MS16734Draeger Medical Systems, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K140017Transonic HCM 102 SystemTransonic Systems, Inc. · 2014 · cites it directly0descendants
- K132528E-Picco Continuous Cardiac Output Module and AccessoriesGE Healthcare Finland Oy · 2014 · cites it directly0descendants
- K073113Infinity Picco Pod, Model MS16734Draeger Medical Systems, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060898 | Pulsion Picco Plus, Model 8100 | Pulsion Medical Systems AG | 2006 | — |
| +1 | K140017 | Transonic HCM 102 System | Transonic Systems, Inc. | 2014 | — |
| +1 | K132528 | E-Picco Continuous Cardiac Output Module and Accessories | GE Healthcare Finland Oy | 2014 | — |
| +1 | K073113 | Infinity Picco Pod, Model MS16734 | Draeger Medical Systems, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140017 (Transonic Systems, Inc., 2014) has gone furthest, with 0 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.
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 PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO Plus presents the derived parameters indexed to body surface area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060898: Pulsion Picco Plus, Model 8100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060898
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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