510(k) · Cleared
ClearedInsulin Algorithms System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insulin Algorithms · NDC Calculator, Drug Dose
Cleared on Jun 7, 2017 as substantially equivalent to K113853 (Glytec, LLC, 2012) and 1 other predicate after a 454-day review. Its family tree reaches back 10 generations to 1994. 1 of the 37 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 7, 2017
- Review
- 454 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941811 (1994). 36 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- 2 generations backK113853 G+ SystemGlytec, LLC · 2012
- 1 generation backK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- This deviceK160673 Insulin Algorithms SystemInsulin Algorithms · 2017
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 5 generations backK023674 Philips Drug Calculator SoftwarePhilips Medical Systems · 2002
- 4 generations backK061110 Glucommander PlusCollaborativemed, LLC · 2006
- 3 generations backK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- 2 generations backK113853 G+ SystemGlytec, LLC · 2012
- 1 generation backK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
- This deviceK160673 Insulin Algorithms SystemInsulin Algorithms · 2017
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump4 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −5 | K023674 | Philips Drug Calculator Software | Philips Medical Systems | 2002 | — |
| −4 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| −3 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| −2 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| −1 | K132547 | Endo Tool Glucose Management System (Egms) | Monarch Medical Technologies | 2014 | 1 |
| 0 (this device) | K160673 | Insulin Algorithms System | Insulin Algorithms | 2017 | — |
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? (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 4…Code: NDC Class: II Panel: Anesthesiology PREDICATE DEVICE • Glucommander System – K113853 • EndoTool Glucose Management System – K132547 SUBSTANTIALLY EQUIVALENT TO: The IA System dev… | 2012 |
| * | K132547 | Endo Tool Glucose Management System (Egms)Summary page 4…Panel: Anesthesiology PREDICATE DEVICE • Glucommander System – K113853 • EndoTool Glucose Management System – K132547 SUBSTANTIALLY EQUIVALENT TO: The IA System device is substantially equivalent in intended use and technological features to the… | 2014 |
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 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 36 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2017, 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?
The Insulin Algorithms System (IA System) is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and…
Read the full statement (207 words)
The Insulin Algorithms System (IA System) is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). The system is designed for use by healthcare professionals. The IA System is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
The IA System is not intended to be used to provide insulin dosing recommendations to the clinician in order to adjust insulin treatment for patients hospitalized in an acute care setting. Also, the IA System is not intended to be used to provide insulin dosing recommendations for patients on insulin pump therapy or IV insulin therapy. Nor is IA System intended to provide recommendations for mealtime injections of insulin that are based on carb counting.
The IA System 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/K160673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160673: Insulin Algorithms System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160673
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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