# K083098: Navigator Applications Suite

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Apr 1, 2009 after 166 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000647 (2000). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071097: Navigator Applications Suite, GE Healthcare Finland Oy (2007) Summary page 1.
- K081941: Navigator Applications Suite, GE Healthcare Finland Oy (2008) Summary page 1.

## Most influential descendants
- K102389: Navigator Applications Suite (2011), 1 descendant of its own
- K103035: Smartpilot View Model MK04500 (2012), 0 descendants of its own

## Indications for use
Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical grade PC physically mounted to the Anesthesia Delivery System and receives data from supported Anesthesia Delivery Systems, Anesthesia Patient Monitors and Intravenous Drug Infusion Pumps. Navigator Therapy displays pharmacokinetic, pharmacodynamic (PK/PD) and synergistic PD modeling information. Navigator Therapy provides the heath care provider with information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient. Models only apply to the following patient populations: Age: 18 - 90 years old Weight: 40Kg - 140 Kg Height 150cm - 190cm Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient. Navigator Protocol allows facilities to load electronic versions of care protocols. This feature can be configured with selected patient monitoring parameters available for viewing in conjunction with the care protocol. Navigator Device is a troubleshooting aid with access to certain Anesthesia Delivery System alarm information. The system is designed for facility use and should only be used under the orders of a clinician.

Source page: https://510kreport.com/device/K083098
Methodology: https://510kreport.com/methodology