# K092219: Navigator Clinical Guidence System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Physiology Pty, Ltd.
- Decided: May 12, 2010 after 294 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 K072735 (2007). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Cited in the summary but kept off the family tree
- K023966: Disposable BI-Polar Cable, Modern Medical Equipment Mfg., Ltd. (2003). Our reading of the summary gave K023966, FDA’s number for Disposable BI-Polar Cable (Modern Medical Equipment Mfg., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PiCCOplus Hemodynamic Monitor”. Kept off the family tree.

## Most influential descendants
- K190955: Hypotension Decision Assist (2019), 1 descendant of its own
- K212529: Hypotension Decision Assist Model HDA-OR2 (2021), 0 descendants of its own

## Indications for use
The Navigator-TM is indicated for the acquisition, processing, and display of hemodynamic parameters, in order to assist the clinician in achieving and maintaining a prescribed target hemodynamic stability. Mean Systemic Filling Pressure (Pms) and Heart Efficiency (Eh) parameters are calculated by the Navigator from Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP) data, obtained directly from patient monitoring equipment, and other data obtained by manual clinician entry. The Navigator system provides a visual indication of the patient's circulatory status in relation to predetermined goals.

Source page: https://510kreport.com/device/K092219
Methodology: https://510kreport.com/methodology