# K102389: Navigator Applications Suite

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: Jun 10, 2011 after 291 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: 9 generations back to K000647 (2000). 12 ancestors in all.
1 later device descends from it; 1 cites 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.
- K083098: Navigator Applications Suite, GE Healthcare Finland Oy (2009) Summary page 1.

## Most influential descendants
- 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 mounted on or near the anesthesia delivery system and receives data from supported anesthesia delivery systems, anesthesia patient monitors, intravenous drug infusion pumps and/or electronic record keeping systems. Navigator Therapy displays pharmacokinetic, pharmacodynamic (PKIPD) and interactive PD modeling information. Navigator Therapy provides the heath care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient. The theoretical models are for the following patient populations: Age 18 - 90 years old Weight 40 - 140 kg / 88.2 to 308.6 pounds Height 150 - 190 cm / 59.1 to 74.8 inches 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 is not intended to be the sole source for patient specific guidance on clinical decisions, including dosing decisions for anesthetic drugs. Always refer to the appropriate drug labeling for dosing information and guidance. Navigator Protocol allows hospitals 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 providing access to certain anesthesia delivery system alarm information. The system is designed for hospital use and should only be used under the orders of a clinician.

Source page: https://510kreport.com/device/K102389
Methodology: https://510kreport.com/methodology