510(k) · Cleared
ClearedEndoTool IV System
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 Aug 7, 2020 as substantially equivalent to K200443 (Monarch Medical Technologies, LLC, 2020) after a 53-day review. Its family tree reaches back 11 generations to 1994. 1 of the 40 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Aug 7, 2020
- Review
- 53 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). 2 later devices descend from it, 1 citing it directly. 1 of the 40 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 backK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020
- This deviceK201619 EndoTool IV SystemMonarch Medical Technologies, LLC · 2020
- Descendant · cites it directly · 1 of its ownK241088 EndoTool IV (3.1)Monarch Medical Technologies · 2024
- Descendant · 2 generations on · 0 of its ownK260910 EndoTool IV Cloud 1.0Glooko, Inc. · 2026
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 backK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020
- This deviceK201619 EndoTool IV SystemMonarch Medical Technologies, LLC · 2020
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump6 generations back · 2004
Most influential descendants
Showing 2 of 2 · See allView 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 | K200443 | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | 2020 | — |
| 0 (this device) | K201619 | EndoTool IV System | Monarch Medical Technologies, LLC | 2020 | — |
| +1 | K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | 2024 | — |
| +2 | K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K200443 | EndoTool IV 1.10Summary page 4…TE DEVICE Predicate Manufacturer: Monarch Medical Technologies Predicate Trade Name: EndoTool IV 1.10 Predicate 510(k): K200443 No reference devices were used in this submission. IV. DEVICE DESCRIPTION EndoTool IV is a software system for glucose manage… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241088 | EndoTool IV (3.1) | 2024 | 1 |
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 26 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, K241088 (Monarch Medical Technologies, 2024) has gone furthest, with 1 descendant 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. 2020, 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 IV is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool IV 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 system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201619 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201619: EndoTool IV System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201619
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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