# K181916: d-Nav System

- Pathway: 510(k) (Traditional)
- Applicant: Hygieia, Inc.
- Decided: Feb 4, 2019 after 202 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011571 (2001). 2 ancestors in all.
1 later device descends 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)
- K082512: Intelligent Dosing System for Insulin-MY Insulin Doser, Dimensional Dosing Systems, Inc. (2008) Summary page 5.

## Most influential descendants
- K253281: UpDoc (2025), 0 descendants of its own

## Indications for use
The d-Nav® System calculates the next dose of insulin to aid in optimizing insulin management. The d-Nav System contains two user-interactive software elements: • The patient user interface software is intended for use by adults with Type 2 diabetes as an aid in optimizing insulin management. It resides on a hand-held device, e.g. cellular phone or enabled glucose meter, and is used to enter glucose event data and receive a recommended insulin dose. • The HCP user interface software tool is intended for use by Health Care Providers (HCPs) to set up the patient software for its intended use. Setup consists of entering the physician-prescribed, patient-specific starting insulin dose instructions (insulin prescription) and sending the information to the patient user software. Insulin instructions include the treatment algorithm (treatment plan), insulin drug, and dose(s). The d-Nav System also contains the d-Nav Get-Dose Library that provides the next insulin dose. The System can receive glucose measurement data entered manually into the patient user software or automatically via the cloud from a linked blood glucose meter. The d-Nav Get-Dose Library Recommend Dose function resides locally on the phone while the d-Nav Get-Dose Library Update Insulin Instruction function may reside locally on the phone or be hosted in the cloud. Configurations are as follows: Model 1: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device. Model 2: Patient user software resides on a hand-held device and uses manual glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud. Model 3: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides locally within the device. Model 4: Patient user software resides on a hand-held device and uses automated glucose measurement entry. The Get-Dose Library Update Insulin Instruction function resides in the cloud. Use of the d-Nav System is limited to Health Care Providers who have been trained by Hygieia or a Hygieia trained person on the use of the d-Nav System, including setup of the patient’s Phone App.

Source page: https://510kreport.com/device/K181916
Methodology: https://510kreport.com/methodology