510(k) · Cleared
ClearedPulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30 Thru -38, PV2022-46 Thru -48)
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 Jun 18, 2010 as substantially equivalent to K072735 (Pulsion Medical Systems AG, 2007) and 2 other predicates after a 366-day review. Its family tree reaches back 1 generation to 2006. 11 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 366 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K053609 (2006). 3 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK053609 Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure…Edwards Lifesciences, LLC · 2006 · Recalled
- This deviceK091786 Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox…Pulsion Medical Systems AG · 2010
- Descendant · cites it directly · 10 of its ownK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
- Descendant · 2 generations on · 9 of its ownK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 6 of its ownK152902 Passport Series Patient Monitors (including Passport 17m, Passport…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · 4 generations on · 3 of its ownK170876 Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
- Descendant · 5 generations on · 1 of its ownK191106 C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America · 2014 · cites it directly10descendants
- K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 2 generations on9descendants
- K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 3 generations on6descendants
- K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 4 generations on3descendants
- K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd · 2019 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac… | Edwards Lifesciences, LLC | 2006 | 6 |
| 0 (this device) | K091786 | Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes… | Pulsion Medical Systems AG | 2010 | — |
| +1 | K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and… | Mindray North America | 2014 | — |
| +2 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 1 |
| +3 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 1 |
| +4 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | — |
| +5 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 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 11.2 · 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? (3)
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 |
|---|---|---|---|
| * | K072735 | Pulsion Picco-2, Model 8500Summary page 1…ammed diagnostic computer (21 CFR 870.1435) Device Product Code: * DXG Legally Marketed Devices to Which Substantial Equivalence Is Claimed: PULSION PICCO-2. MODEL 8500 K072735 VIGILEO ARTERIAL PRESSURE CARDIAC K062134 OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES LLC PRESEP AND K053609 PEDIASAT OXIMETRY C… | 2007 |
| * | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorSummary page 1…5) Device Product Code: * DXG Legally Marketed Devices to Which Substantial Equivalence Is Claimed: PULSION PICCO-2. MODEL 8500 K072735 VIGILEO ARTERIAL PRESSURE CARDIAC K062134 OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES LLC PRESEP AND K053609 PEDIASAT OXIMETRY CATHETERS May, 2010 CeVOX™ Accessories to P… | 2006 |
| * | K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…Summary page 1…tantial Equivalence Is Claimed: PULSION PICCO-2. MODEL 8500 K072735 VIGILEO ARTERIAL PRESSURE CARDIAC K062134 OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES LLC PRESEP AND K053609 PEDIASAT OXIMETRY CATHETERS May, 2010 CeVOX™ Accessories to PICCO-2 Page 3-1 14C G G =N Ga D G =D N I G oGF D N P… | 2006 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) | 2014 | 10 |
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?
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. 2010, 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. With the optional Cevox™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 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 PICCO-2…
Read the full statement (118 words)
The PULSION PICCO-2 Is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional Cevox™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 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 PICCO-2 measures heart rate, systolic, and diastolic and derives mean arterlial and central vengus pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluld volumes. If a patient’s weight and height are entered, the PICCO-2 monitor presents the derived parameters indexed to bady surface area.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091786: Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30 Thru -38, PV2022-46 Thru -48).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091786
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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