510(k) · Cleared
ClearedIbgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agamatrix, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Dec 7, 2011 as substantially equivalent to K071393 (Agamatrix, 2007) and 1 other predicate after a 370-day review. Its family tree reaches back 4 generations to 1995. 9 later devices descend from it.
- Decided
- Dec 7, 2011
- Review
- 370 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K952279 (1995). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 3 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 2 generations backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
- 1 generation backK101597 Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
- This deviceK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK131230 Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK150817 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK152365 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK130535 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK172723 Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014 · cites it directly4descendants
- K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · 2 generations on2descendants
- K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016 · cites it directly1descendant
- K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc. · 2013 · cites it directly1descendant
- K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −3 | K994433 | Connect Data Management System | Abbott Diabetes Care, Inc. | 2000 | 1 |
| −2 | K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | 2006 | — |
| −1 | K101597 | Wavesense Diabetes Manager Model Version 1.3.4 | Agamatrix | 2010 | — |
| 0 (this device) | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application… | Agamatrix, Inc. | 2011 | — |
| +1 | K131230 | Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application | Philosys, Inc. | 2014 | — |
| +2 | K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2015 | 1 |
| +1 | K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | 2016 | — |
| +1 | K130535 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application | Agamatrix, Inc. | 2013 | — |
| +3 | K172723 | Dario LC Blood Glucose Monitoring System | Labstyle Innovation, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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.
Planning a device in NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 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 |
|---|---|---|---|
| * | K071393 | Jazz Blood Glucose Monitoring SystemSummary page 1…Calculator/data processing | Class 1 21 CFR 862.2100 75, Clinical Chemistry module for clinical use. Predicate Device: 1) Jazz Blood Glucose Monitoring System, 510(k) # k071393 2) WaveSense Diabetes Manager, 510(k) # 5101597 Device Description: The iBGStar Blood Glucose Monitoring System consists of: o i… | 2007 |
| * | K101597 | Wavesense Diabetes Manager Model Version 1.3.4Summary page 1…100 75, Clinical Chemistry module for clinical use. Predicate Device: 1) Jazz Blood Glucose Monitoring System, 510(k) # k071393 2) WaveSense Diabetes Manager, 510(k) # 5101597 Device Description: The iBGStar Blood Glucose Monitoring System consists of: o iBGStar Blood Glucose Meter ° BGStar Test Strips… | 2010 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131230 (Philosys, Inc., 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The iBGStar™ Blood Glucose Monitoring System is Intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single pauenl and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (In vitro diagnostic use) by people with…
Read the full statement (262 words)
The iBGStar™ Blood Glucose Monitoring System is Intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single pauenl and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and forearm testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly).
BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performmg correctly.
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103544 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103544
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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