510(k) · Cleared
Clearedd-Nav System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygieia, Inc. · NDC Calculator, Drug Dose
Cleared on Feb 4, 2019 as substantially equivalent to K082512 (Dimensional Dosing Systems, Inc., 2008) after a 202-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Feb 4, 2019
- Review
- 202 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011571 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
- 1 generation backK082512 Intelligent Dosing System for Insulin-MY Insulin DoserDimensional Dosing Systems, Inc. · 2008
- This deviceK181916 d-Nav SystemHygieia, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253281 UpDocUpdoc, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253281UpDocUpdoc, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | 2001 | — |
| −1 | K082512 | Intelligent Dosing System for Insulin-MY Insulin Doser | Dimensional Dosing Systems, Inc. | 2008 | — |
| 0 (this device) | K181916 | d-Nav System | Hygieia, Inc. | 2019 | — |
| +1 | K253281 | UpDoc | Updoc, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDC device
- #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082512 | Intelligent Dosing System for Insulin-MY Insulin DoserSummary page 5…K181916 My Insulin Doser (MID) k082512 Device Calculator, Drug Dose Same Classification Name: Predictive pulmonary-function… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253281 | UpDoc | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253281 (Updoc, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082512.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
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. •…
Read the full statement (356 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181916: d-Nav System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026