510(k) · Cleared
ClearedEndoTool SubQ 2.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monarch Medical Technologies, LLC · NDC Calculator, Drug Dose
Cleared on Oct 28, 2021 as substantially equivalent to K180366 (Al Pacheco and Associates, 2018) after a 192-day review. Its family tree reaches back 12 generations to 1994. 1 of the 39 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 28, 2021
- Review
- 192 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K941811 (1994). 38 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations between
- 3 generations backK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- 2 generations backK142918 EndoTool SubQMonarch Medical Technologies · 2015
- 1 generation backK180366 EndoTool SubQAl Pacheco and Associates · 2018
- This deviceK211160 EndoTool SubQ 2.1Monarch Medical Technologies, LLC · 2021
Show all 12 generations
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 10 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 9 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 8 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 7 generations backK023674 Philips Drug Calculator SoftwarePhilips Medical Systems · 2002
- 6 generations backK061110 Glucommander PlusCollaborativemed, LLC · 2006
- 5 generations backK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- 4 generations backK113853 G+ SystemGlytec, LLC · 2012
- 3 generations backK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- 2 generations backK142918 EndoTool SubQMonarch Medical Technologies · 2015
- 1 generation backK180366 EndoTool SubQAl Pacheco and Associates · 2018
- This deviceK211160 EndoTool SubQ 2.1Monarch Medical Technologies, LLC · 2021
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump6 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −11 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −10 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −9 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −8 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −7 | K023674 | Philips Drug Calculator Software | Philips Medical Systems | 2002 | — |
| −6 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| −5 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| −4 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| −3 | K132547 | Endo Tool Glucose Management System (Egms) | Monarch Medical Technologies | 2014 | 1 |
| −2 | K142918 | EndoTool SubQ | Monarch Medical Technologies | 2015 | — |
| −1 | K180366 | EndoTool SubQ | Al Pacheco and Associates | 2018 | — |
| 0 (this device) | K211160 | EndoTool SubQ 2.1 | Monarch Medical Technologies, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDC device
- #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180366 | EndoTool SubQSummary page 4…NDC, Calculator, Drug Dose Regulation: 21 CFR 868.1890, Predictive pulmonary-function value calculator Substantial Equivalence claimed to: EndoTool SubQ (K180366) Description: EndoTool SubQ 2.1 is a software application for use by trained healthcare professionals to calculate and recommend… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K042873Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 9 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 38 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
EndoTool SubQ 2.1 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 hyperglycemia including 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…
Read the full statement (147 words)
EndoTool SubQ 2.1 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 hyperglycemia including 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.
EndoTool SubQ 2.1 logic is not a substitute for clinical reasoning but an aid for trained healthcare professionals based on obtained glucose readings and entered clinical data. Final dose recommendations 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 upon the results provided by this software program.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211160: EndoTool SubQ 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211160
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026