EndoTool SubQ

K142918

MONARCH MEDICAL TECHNOLOGIES · cleared 2015-04-24 · product code NDC · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both adult and pediatric patients (age 2 years and above and 12 kg or more).”
AlgorithmThe EndoTool SubQ Glucose Management System uses feedback mathematics to individualize insulin dosing by calculating limited proportional incremental changes in the insulin dosing model (total daily dose and the physician set basal/bolus distribution) or carbohydrate recommendations based on a patient's previous blood glucose readings in response to prior insulin doses. These calculations are repeated by the software when new data is entered into the system, constantly seeking the optimal, patient specific insulin dose for the targets set by the physician. The system is installed on a server and deployed via an internal website on the hospital's infrastructure. Insulin and carbohydrate therapy are managed using blood glucose measurements, available patient information and a set of algorithms that includes a nonlinear dosing equation that is individualized and optimized through time based on blood glucose response to previous doses administered.
source quote (p.5)
“The EndoTool SubQ Glucose Management System uses feedback mathematics to individualize insulin dosing by calculating limited proportional incremental changes in the insulin dosing model (total daily dose and the physician set basal/bolus distribution) or carbohydrate recommendations based on a patient's previous blood glucose readings in response to prior insulin doses. These calculations are repeated by the software when new data is entered into the system, constantly seeking the optimal, patient specific insulin dose for the targets set by the physician. The system is installed on a server and deployed via an internal website on the hospital's infrastructure. Insulin and carbohydrate therapy are managed using blood glucose measurements, available patient information and a set of algorithms that includes a nonlinear dosing equation that is individualized and optimized through time based on blood glucose response to previous doses administered.”
Adaptive (vs locked)No
source quote (p.5)
“The EndoTool SubQ Glucose Management System uses feedback mathematics to individualize insulin dosing by calculating limited proportional incremental changes in the insulin dosing model (total daily dose and the physician set basal/bolus distribution) or carbohydrate recommendations based on a patient's previous blood glucose readings in response to prior insulin doses. These calculations are repeated by the software when new data is entered into the system, constantly seeking the optimal, patient specific insulin dose for the targets set by the physician. The system is installed on a server and deployed via an internal website on the hospital's infrastructure. Insulin and carbohydrate therapy are managed using blood glucose measurements, available patient information and a set of algorithms that includes a nonlinear dosing equation that is individualized and optimized through time based on blood glucose response to previous doses administered.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Requirements-based testing for all functionality.; Requirements-based testing for all risk-related requirements.; Integration testing to ensure that data flows correctly into and out of the database.; Automated algorithm test case execution.; Off The Shelf (OTS) software embedded in the application was included in the technical verification protocols. Each OTS component was tested to ensure that it functioned as intended.

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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Monarch Medical Technologies) — same firm and product code, not necessarily this device · initiated 2019-10-01

    Product was distributed prior to approval or clearance from FDA.

    recall event 83926 (openFDA)

  • Recalling firm matches this device's applicant (Monarch Medical Technologies) — same firm and product code, not necessarily this device · initiated 2019-05-03

    Insulin dosing calculations were erroneously high.

    recall event 82828 (openFDA)

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/K142918