510(k) · Cleared
Recalled · Class II · 2019Endo Tool Glucose Management System (Egms)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monarch Medical Technologies · NDC Calculator, Drug Dose
Cleared on Apr 17, 2014 as substantially equivalent to K113853 (Glytec, LLC, 2012) and 1 other predicate after a 247-day review. Its family tree reaches back 9 generations to 1994. 1 of the 44 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Apr 17, 2014
- Review
- 247 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K941811 (1994). 35 ancestors in all, the oldest K822695 (1982). 8 later devices descend from it, 3 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK061110 Glucommander PlusCollaborativemed, LLC · 2006
- 2 generations backK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- 1 generation backK113853 G+ SystemGlytec, LLC · 2012
- This deviceK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014
- Descendant · cites it directly · 3 of its ownK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020
- Descendant · 2 generations on · 2 of its ownK201619 EndoTool IV SystemMonarch Medical Technologies, LLC · 2020
- Descendant · cites it directly · 2 of its ownK142918 EndoTool SubQMonarch Medical Technologies · 2015
- Descendant · 3 generations on · 1 of its ownK241088 EndoTool IV (3.1)Monarch Medical Technologies · 2024
- Descendant · 2 generations on · 1 of its ownK180366 EndoTool SubQAl Pacheco and Associates · 2018
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 4 generations backK023674 Philips Drug Calculator SoftwarePhilips Medical Systems · 2002
- 3 generations backK061110 Glucommander PlusCollaborativemed, LLC · 2006
- 2 generations backK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- 1 generation backK113853 G+ SystemGlytec, LLC · 2012
- This deviceK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump4 generations back · 2004
Most influential descendants
Showing 5 of 8 · See all- K200443EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020 · cites it directly3descendants
- K201619EndoTool IV SystemMonarch Medical Technologies, LLC · 2020 · 2 generations on2descendants
- K142918EndoTool SubQMonarch Medical Technologies · 2015 · cites it directly2descendants
- K241088EndoTool IV (3.1)Monarch Medical Technologies · 2024 · 3 generations on1descendant
- K180366EndoTool SubQAl Pacheco and Associates · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −4 | K023674 | Philips Drug Calculator Software | Philips Medical Systems | 2002 | — |
| −3 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| −2 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| −1 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| 0 (this device) | K132547 | Endo Tool Glucose Management System (Egms) | Monarch Medical Technologies | 2014 | — |
| +1 | K200443 | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | 2020 | — |
| +2 | K201619 | EndoTool IV System | Monarch Medical Technologies, LLC | 2020 | — |
| +1 | K142918 | EndoTool SubQ | Monarch Medical Technologies | 2015 | — |
| +3 | K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | 2024 | — |
| +2 | K180366 | EndoTool SubQ | Al Pacheco and Associates | 2018 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K113853 | G+ SystemSummary page 1…Name: Predictive pulmonary-function value calculator Device Classification: Class 11 Regulation Number: 21 CFR 868.1890 Product Code: NDC Predicate Devices: K113853 - Glytec LLC, G+System K053137 - MD Scientific Inc., EndloToo[ Drug Dose Calculator Indications for Use:… | 2012 |
| * | K053137 | Endotool Drug Dose CalculatorSummary page 1…alue calculator Device Classification: Class 11 Regulation Number: 21 CFR 868.1890 Product Code: NDC Predicate Devices: K113853 - Glytec LLC, G+System K053137 - MD Scientific Inc., EndloToo[ Drug Dose Calculator Indications for Use: By evaluating current and cumul… | 2006 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2019 | Class II | Z-1786-2019 | Software change control | Insulin dosing calculations were erroneously high. |
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 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200443 (Monarch Medical Technologies, LLC, 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K113853.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
By evaluating current and cumulative blood glucose levels, the Endo-rool Glucose Management Sysstem (EGMS) - a glycemic management software support program is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician-determined target range. The EndoTool Drug Delivery Calculator…
Read the full statement (115 words)
By evaluating current and cumulative blood glucose levels, the Endo-rool Glucose Management Sysstem (EGMS) - a glycemic management software support program is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician-determined target range.
The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more.
The EGMS logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132547: Endo Tool Glucose Management System (Egms).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132547
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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