d-Nav System

K181916

Hygieia, Inc · cleared 2019-02-04 · product code NDC · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The d-Nav System is a software-based, prescription-only product designed to provide the next insulin dose recommendation as an aid for personal insulin management.”
AlgorithmA response-to-dose calculator algorithm that relies on current responses (e.g. blood glucose readings), current insulin instruction dose components, and a target response (e.g. blood glucose level) to calculate the next insulin dose recommendation. The subject device uses both a single dose to calculate dose reductions and a weekly average based on the relative time point for that insulin dose (i.e. breakfast, or bedtime) to calculate both dose increases and decreases.
source quote (p.15)
“Use a response-to-dose calculator algorithm that relies on current responses (e.g. blood glucose readings), current insulin instruction dose components, and a target response (e.g. blood glucose level) to calculate the next insulin dose recommendation The subject device uses both a single dose to calculate dose reductions and a weekly average based on the relative time point for that insulin dose (i.e. breakfast, or bedtime) to calculate both dose increases and decreases.”
Adaptive (vs locked)Yes
source quote (p.15)
“The subject device uses both a single dose to calculate dose reductions and a weekly average based on the relative time point for that insulin dose (i.e. breakfast, or bedtime) to calculate both dose increases and decreases.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.17)
“A cybersecurity evaluation was conducted to ensure the mitigation of cybersecurity risks according to the FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”

Validation studies (3)

Bench

sample size not stated

standards: ISO 14971: 2007 – Medical devices — Application of risk management to medical devices.

Bench

sample size not stated

standards: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (May 11, 2005)

Bench

sample size not stated

standards: FDA Guidance – applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

2
recalls in product code, 24mo
511
MAUDE reports in code, 12mo
+62%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code NDC (Medtronic MiniMed, Inc., initiated 2025-11-13): "When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97904

  • recall_reason_pattern

    Software/algorithm-related recall in product code NDC (Medtronic MiniMed, Inc., initiated 2025-06-16): "Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommen" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97237

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Anesthesiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K181916