510(k) · Cleared
ClearedEndoTool SubQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Al Pacheco and Associates · NDC Calculator, Drug Dose
Cleared on Sep 20, 2018 as substantially equivalent to K142918 (Monarch Medical Technologies, 2015) after a 220-day review. Its family tree reaches back 11 generations to 1994. 1 of the 39 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 20, 2018
- Review
- 220 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K941811 (1994). 37 ancestors in all, the oldest K822695 (1982). 1 later device descends from it, 1 citing it directly. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations between
- 3 generations backK113853 G+ SystemGlytec, LLC · 2012
- 2 generations backK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- 1 generation backK142918 EndoTool SubQMonarch Medical Technologies · 2015
- This deviceK180366 EndoTool SubQAl Pacheco and Associates · 2018
- Descendant · cites it directly · 0 of its ownK211160 EndoTool SubQ 2.1Monarch Medical Technologies, LLC · 2021
Show all 11 generations
- Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 9 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 8 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 7 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 6 generations backK023674 Philips Drug Calculator SoftwarePhilips Medical Systems · 2002
- 5 generations backK061110 Glucommander PlusCollaborativemed, LLC · 2006
- 4 generations backK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- 3 generations backK113853 G+ SystemGlytec, LLC · 2012
- 2 generations backK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- 1 generation backK142918 EndoTool SubQMonarch Medical Technologies · 2015
- This deviceK180366 EndoTool SubQAl Pacheco and Associates · 2018
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump5 generations back · 2004
Most influential descendants
Showing 1 of 1 · See all- K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −10 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −9 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −8 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −7 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −6 | K023674 | Philips Drug Calculator Software | Philips Medical Systems | 2002 | — |
| −5 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| −4 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| −3 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| −2 | K132547 | Endo Tool Glucose Management System (Egms) | Monarch Medical Technologies | 2014 | 1 |
| −1 | K142918 | EndoTool SubQ | Monarch Medical Technologies | 2015 | — |
| 0 (this device) | K180366 | EndoTool SubQ | Al Pacheco and Associates | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K142918 | EndoTool SubQSummary page 4…8.1890 Product Code: NDC Device Class: Class II Primary Predicate Device: K142918 – EndoTool® SubQ Device Indications For Use: EndoTool SubQ is a software management system for use by trained healthcare profes… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211160 | EndoTool SubQ 2.1 | 2021 | 0 |
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 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 37 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211160 (Monarch Medical Technologies, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 is a software management system for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage elevated blood glucose levels in both adult and pediatric patients (age 2 and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and on occasion a carbohydrate dose for the treatment of hypoglycemia) based on the…
Read the full statement (193 words)
EndoTool SubQ is a software management system for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage elevated blood glucose levels in both adult and pediatric patients (age 2 and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and on occasion a carbohydrate dose for the treatment of hypoglycemia) based on the prescribing healthcare provider’s insulin regimen, target glucose level range, and nutritional regimen. The software provides an optional insulin-on-board (IOB) calculation that estimates the sum of the remaining insulin activity from previously administered subcutaneous insulin(s). This IOB adjustment reduces the prescribed Bolus dose and, if appropriate, recommends a supplemental carbohydrate dose to the trained healthcare professional.
EndoTool SubQ is not a substitute for clinical reasoning, but rather an aid for trained healthcare professionals based on timely, accurately obtained glucose readings and timely, accurately entered clinical data. Final dose recommendations for a patient must be accepted only after consideration of the full clinical status of the patient. No medical decision should be made based solely upon the recommendations provided by this software program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180366: EndoTool SubQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180366
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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