510(k) · Cleared
ClearedE-Picco Continuous Cardiac Output Module and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare Finland Oy · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jan 16, 2014 as substantially equivalent to K060898 (Pulsion Medical Systems AG, 2006) after a 157-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Jan 16, 2014
- Review
- 157 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060898 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060898 Pulsion Picco Plus, Model 8100Pulsion Medical Systems AG · 2006
- This deviceK132528 E-Picco Continuous Cardiac Output Module and AccessoriesGE Healthcare Finland Oy · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060898 | Pulsion Picco Plus, Model 8100 | Pulsion Medical Systems AG | 2006 | — |
| 0 (this device) | K132528 | E-Picco Continuous Cardiac Output Module and Accessories | GE Healthcare Finland Oy | 2014 | — |
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 |
|---|---|---|---|
| * | K060898 | Pulsion Picco Plus, Model 8100Summary page 1…cation Names: 21 CFR 870.1435 Single-function, preprogrammed diagnostic computer, Product Code: DXC Predicate Device(s) K060898 Pulsion PiCCO Plus (807.92(a)(3):: Device Description The E-PiCCO Continuous Cardiac Output Module and accesso… | 2006 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K060898.
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. 2014, 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?
Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO 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 E-PiCCO measures systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and…
Read the full statement (272 words)
Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO 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 E-PiCCO measures 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 compatible patient monitor presents the derived parameters indexed to body surface area. The E-PiCCO is intended for hospitalized patients. The E-PiCCO and accessories are for use by qualified medical personnel only. The E-PiCCO patient module is intended for use on one patient at a time. Cardiac output measurement with E-PiCCO is intended for patients weighing over 2 kg (4.4 lb) and therefore it is not available for smaller patients. E-PiCCO indexed values are available for patients weighing over 15 kg (33 lb) only.
Indications for use PiCCO Continuous Cardiac Output Cable (M 1154585): The reusable, continuous cardiac output adapter cables are intended to be used for connecting a continuous cardiac output catheter to GE Medical Systems Information Technologies monitoring equipment requiring a rectangular 11I-pin connector cable. These accessories are indicated for use by qualified medical personnel only.
Indications for use PiCCO Iniectate Sensor Cable (Ml 182448): The reusable PiCCO Injectate Sensor Cable (Ml 182448) is intended to be used for connecting the PiCCO Injectate Sensor Housing* (PV4046) to PiCCO Continuous Cardiac Output Cable (MI 154585) of GE Healthcare monitoring equipment. These accessories are indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132528: E-Picco Continuous Cardiac Output Module and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132528
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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