# K091786: Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable  Probes (PV2022-30 Thru -38, PV2022-46 Thru -48)

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems AG
- Decided: Jun 18, 2010 after 366 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K053609 (2006). 3 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072735: Pulsion Picco-2, Model 8500, Pulsion Medical Systems AG (2007) Summary page 1.
- K062134: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2006) Summary page 1.
- K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Edwards Lifesciences, LLC (2006) Summary page 1.

## Most influential descendants
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) (2014), 10 descendants of its own
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (2014), 9 descendants of its own
- K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (2016), 6 descendants of its own
- K170876: Passport Series Patient Monitors (Passport 12m, Passport 17m) (2017), 3 descendants of its own
- K191106: C50 and C80 Multi-parameter Patient Monitor (2019), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091786
Methodology: https://510kreport.com/methodology