Anesthesiology · 510(k) · 2019
d-Nav System
Hygieia, Inc. Cleared by FDA on 4 February 2019 under submission K181916, product code NDC (calculator, drug dose). What FDA's record says, in FDA's words.
Device record · K181916
- Device. d-Nav SystemDEVICE
- Company. Hygieia, IncCOMPANY
- Decision. 4 February 2019, 510(k), substantially equivalent (traditional review); received 17 July 2018DECISION
- Panel. AnesthesiologyPANEL
- Product code. NDC, Calculator, Drug DoseCODE
- Regulation. 21 CFR 868.1890, Class IIREG
- Source. FDA database entry · decision document (18 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The d-Nav System calculates the next dose of insulin to aid in optimizing insulin management. The dNav 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 […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,093 reports filed against devices carrying product code NDC. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Injury · MiniMed 780G US System BLE Connect 3.0 mg/dL · Medtronic Puerto Rico Operations Co. · report 2032227-2026-246863
It was reported to Minimed that the customer experienced Hyperglycemia. Blood glucose value at the time of event was 600 mg/dL. The customer was treated with Insulin Pump. The customer also received sensor updating alert. The event involved products UNK_RESERVOIR,MMT-1884,UNOMEDICAL,78893-01. Troubleshooting was not performed. There was no mention of the Auto mode feature at the time of the event. It was unknown whether the customer was using the insulin pump system within 48 hours of reported […]
30 September 2026 · Malfunction · Unknown MiniMed GO · MEDTRONIC MINIMED · report 2032227-2026-246953
It was reported to Minimed that the customer experienced pain, redness and cut on the sensor insertion site. The customer reported sensor updating alert and loss of communication between instinct sensor and minimed go application. The event involved product(s) 78893-01, UNK_MINIMEDGO. Troubleshooting was performed. The customer was advised to move mobile and sensor closer together, force close the application, turn bluetooth on/off and restart mobile. Connection did not re-establish. The […]
30 September 2026 · Malfunction · SW MMT-8600 MiniMed GO iOS · MEDTRONIC MINIMED · report 2032227-2026-247180
It was reported to Minimed that the customer experienced loss of communication between transmitter and mobile application and received a "Lost Sensor Signal" alert. The customer reported no adverse event. The event involved product(s) MMT-8600. Troubleshooting was performed. Unpairing/repairing sensor to mobile did not resolve issue. Instructions were provided to resolve the issue, no escalation required. No harm requiring medical intervention was reported. A product return is not applicable […]
30 September 2026 · Malfunction · SW MMT-8601 MiniMed Go Android · MEDTRONIC MINIMED · report 2032227-2026-247205
29 September 2026 · Injury · MiniMed 780G US System BLE Connect 3.0 mg/dL · Medtronic Puerto Rico Operations Co. · report 2032227-2026-246175
It was reported to Minimed that the customer experienced the sensor not working and was unable to pair the pump and transmitter, resulting in hyperglycemia that was treated with manual injection. The blood glucose value at the time of the event was 447 mg/dL. The event involved product(s): MMT-1884, MMT-441AG, MMT-7040A and MMT-342G. Troubleshooting was not performed and, it was not known whether the auto mode feature was active at the time of the event and whether the pump was used within 48 […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NDC, in Anesthesiology, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.