510(k) · Cleared
ClearedGlucocare Intensive Glycemic Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pronia Medical System, LLC · NDC Calculator, Drug Dose
Cleared on Aug 21, 2008 as substantially equivalent to K053137 (MD Scientific, LLC, 2006) and 1 other predicate after a 94-day review. Its family tree reaches back 8 generations to 1994. 1 of the 35 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 21, 2008
- Review
- 94 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K941811 (1994). 34 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 3 generations backK023674 Philips Drug Calculator SoftwarePhilips Medical Systems · 2002
- 2 generations backK061110 Glucommander PlusCollaborativemed, LLC · 2006
- 1 generation backK071713 Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network · 2007
- This deviceK081388 Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC · 2008
Class I recalls in this family
- K042873 Animas Model IR1250 Insulin Infusion Pump3 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −3 | K023674 | Philips Drug Calculator Software | Philips Medical Systems | 2002 | — |
| −2 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| −1 | K071713 | Clarian Glucose Stabilizer Insulin Dosing Calculator | Medical Decisions Network | 2007 | — |
| 0 (this device) | K081388 | Glucocare Intensive Glycemic Control System | Pronia Medical System, LLC | 2008 | — |
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 |
|---|---|---|---|
| * | K053137 | Endotool Drug Dose CalculatorSummary page 1…ation: Class II (per 21 CFR 868.1890) Product Code: NDC 3. PREDICATE DEVICES * EndoToolTm Glucose Management System, K053 137 * MDN-CGSTM Insulin Dosing Calculator, K07 1713 4. DEVICE DESCRIPTION The GlucoCare IGC System is a software p… | 2006 |
| * | K071713 | Clarian Glucose Stabilizer Insulin Dosing CalculatorSummary page 1…Product Code: NDC 3. PREDICATE DEVICES * EndoToolTm Glucose Management System, K053 137 * MDN-CGSTM Insulin Dosing Calculator, K07 1713 4. DEVICE DESCRIPTION The GlucoCare IGC System is a software program that implements an insulin infusion protocol… | 2007 |
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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 34 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K053137.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels in the hospital setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of intravenously administered insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The…
Read the full statement (123 words)
The GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels in the hospital setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of intravenously administered insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The information provided by the software is intended to be used as a tool by qualified and trained medical personnel. The GlucoCare IGC System software is intended for use in patients over the age of 18 with no known insulin allergies. The device is not intended for use in patients with diabetic ketoacidosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081388: Glucocare Intensive Glycemic Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081388
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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