DreaMed Advisor Pro

K191370

DreaMed Diabetes Ltd · cleared 2019-07-18 · product code QCC · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians”
AlgorithmAlgorithmic software device that gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS) to generate recommendations for adjustments to the patient's insulin therapy parameters.
source quote (p.4)
“DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG). The DreaMed Advisor Pro gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care. Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity). DreaMed Advisor Pro may also advise behavioral changes.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Data is transmitted from DMS to Advisor device using SSL mechanism, JSON data structure. Integrity checks, accuracy checks, reliability checks are performed throughout the data transmission from the data system, to the algorithm and from the algorithm back to the data system”

Validation studies (2)

Bench

sample size not stated

endpoints: confirmed that the DreaMed Advisor Pro performs according to the stated intended use; All test results fell within the pre-determined specification parameters and acceptance criteria

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

Retrospective clinical

n=15 patients

endpoints: evaluate physicians' strategies of adjustment of insulin pump settings based on glucometer and pump data alone for patients with type 1 diabetes; compare results to automated recommendations given by the DreaMed Advisor Pro; examine the level of agreement between one expert to his colleague; examine the level of agreement between DreaMed Advisor Pro recommendations and experts

Reported performance (1 observation)

agreement_kappaas written: “level of agreement between DreaMed Advisor Pro recommendations and experts”stated without value
source quote (p.6)
“The study results show that the recommendations of the DreaMed Advisor Pro when is based on SMBG data alone were significantly as good as the recommendations of expert in the basal, CR and in the CF plan with regards to the direction of change.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 Clinical Chemistry 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/K191370