510(k) · Cleared
ClearedPulsion Picco-2, Model 8500
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 Oct 18, 2007 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 72 devices in its family, counting itself, has a Class I recall. 71 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 4 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- This deviceK072735 Pulsion Picco-2, Model 8500Pulsion Medical Systems AG · 2007
- Descendant · cites it directly · 55 of its ownK100709 EV1000 Platform Model: EV1000A, EV1000DB, EV1000MEdwards Lifesciences, LLC · 2010
- Descendant · cites it directly · 54 of its ownK110597 EV1000 Clinical PlatformEdwards Lifesciences · 2011
- Descendant · 2 generations on · 52 of its ownK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- Descendant · 2 generations on · 52 of its ownK131892 EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014
- Descendant · 3 generations on · 51 of its ownK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…3 generations on · 2016
Most influential descendants
Showing 5 of 71 · See all- K100709EV1000 Platform Model: EV1000A, EV1000DB, EV1000MEdwards Lifesciences, LLC · 2010 · cites it directly55descendants
- K110597EV1000 Clinical PlatformEdwards Lifesciences · 2011 · cites it directly54descendants
- K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC · 2014 · 2 generations on52descendants
- K131892EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014 · 2 generations on52descendants
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC · 2016 · 3 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072735 | Pulsion Picco-2, Model 8500 | Pulsion Medical Systems AG | 2007 | — |
| +1 | K100709 | EV1000 Platform Model: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010 | — |
| +1 | K110597 | EV1000 Clinical Platform | Edwards Lifesciences | 2011 | — |
| +2 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| +2 | K131892 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2014 | — |
| +3 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 1 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 9 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 11 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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 11.2 · 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? (71)
See all 714 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K100709 (Edwards Lifesciences, LLC, 2010) has gone furthest, with 55 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. 2007, 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 PiCCO-2 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-2 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-2 presents the derived parameters indexed to body surface area.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072735: Pulsion Picco-2, Model 8500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072735
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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