WellDoc BlueStar

K190013

WellDoc, Inc. · cleared 2019-11-04 · product code MRZ · General Hospital

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have Type 1 or Type 2 Diabetes.”
Algorithmlinear decay model to model the Insulin on Board decay
source quote (p.10)
“Both the subject device and reference device use a well-understood and accepted linear decay model to model the Insulin on Board decay.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.11)
“Cybersecurity was evaluated per the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff, (October 2, 2014). Specifically, addressing the following areas: Identify and Protect, Detect, Response and Recover”

Validation studies (2)

Bench

sample size not stated

standards: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern, FDA Guidance “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices"

Bench

sample size not stated

endpoints: confirm that the user interface has been adequately validated for use per the labeling

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

0
recalls in product code, 24mo
5
MAUDE reports in code, 12mo
-86%
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 General Hospital 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/K190013