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Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30 thru -38, PV2022-46 thru -48)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091786

by Pulsion Medical Systems AG

Identifiers

510(k) Number
K091786 FDA 510(k)
FDA Product Code
DXG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1435 FDA 510(k)
Regulation Number
870.1435 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a computer, diagnostic, pre-programmed, single-function system for hemodynamic monitoring. It is substantially equivalent to a predicate device and classified under regulation number 870.1435 with product code DXG.

It is supplied by Pulsion Medical Systems AG and authorized under FDA 510(k) clearance K091786. The system includes the PiCCO2 unit (8500), Cevox optical module (PC3015), and disposable probes (PV2022-30 through -38 and PV2022-46 through -48).

Frequently asked questions

What is the PULSION PICCO2 system used for?

The PULSION PICCO2 system is a computer, diagnostic, pre-programmed, single-function system designed for hemodynamic monitoring, as stated in its description and classification under regulation number 870.1435.

What components are included in the PULSION PICCO2 system?

The system includes the PiCCO2 unit (model 8500), the Cevox optical module (model PC3015), and disposable probes ranging from PV2022-30 through -38 and PV2022-46 through -48, all supplied by Pulsion Medical Systems AG.

Are the probes in the PULSION PICCO2 system reusable or disposable?

The probes (PV2022-30 through -38 and PV2022-46 through -48) are explicitly designated as disposable in the device name and specifications, indicating they are intended for single-use only.

How was the PULSION PICCO2 system authorized for market?

The system was authorized under FDA 510(k) clearance K091786, which determined it to be substantially equivalent to a predicate device, as reflected in the decision code SESE and clearance type Traditional.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Download PULSION PiCCO2 Operator's Manual And Product Information ..., Pulsion Medical Systems - Picco2 Community, Manuals and ... - MedWrench, PULSION Medical Systems PiCCO2 System - 5 related documents available, Pulsion Medical Systems Picco2 Manuals / Documents, PiCCO2 Technical Datasheet - PULSION Medical Systems SE - Yumpu

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulsion Medical Systems AG

Sources (1)

  • FDA 510(k) K091786 24 fields · synced Sep 26, 2026