Anesthesiology · 510(k) · 2015
EndoTool SubQ
MONARCH MEDICAL TECHNOLOGIES. Cleared by FDA on 24 April 2015 under submission K142918, product code NDC (calculator, drug dose). What FDA's record says, in FDA's words.
Device record · K142918
- Device. EndoTool SubQDEVICE
- Company. MONARCH MEDICAL TECHNOLOGIESCOMPANY
- Decision. 24 April 2015, 510(k), substantially equivalent (traditional review); received 7 October 2014DECISION
- Panel. AnesthesiologyPANEL
- Product code. NDC, Calculator, Drug DoseCODE
- Regulation. 21 CFR 868.1890, Class IIREG
- Source. FDA database entry · decision document (6 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.
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). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider’s nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics. The EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.
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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsadult patients
- Mentionspediatric 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 2015. 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.