510(k) · Cleared
ClearedIbgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application
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 Apr 17, 2013 as substantially equivalent to K103544 (Agamatrix, Inc., 2011) after a 47-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Apr 17, 2013
- Review
- 47 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K952279 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 4 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 3 generations backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
- 2 generations backK101597 Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
- 1 generation backK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
- This deviceK130535 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK132148 S HealthSamsung Electronics Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132148S HealthSamsung Electronics Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −4 | K994433 | Connect Data Management System | Abbott Diabetes Care, Inc. | 2000 | 1 |
| −3 | K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | 2006 | — |
| −2 | K101597 | Wavesense Diabetes Manager Model Version 1.3.4 | Agamatrix | 2010 | — |
| −1 | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application… | Agamatrix, Inc. | 2011 | — |
| 0 (this device) | K130535 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application | Agamatrix, Inc. | 2013 | — |
| +1 | K132148 | S Health | Samsung Electronics Co., Ltd. | 2013 | — |
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 | 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? (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 |
|---|---|---|---|
| * | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DSummary page 1…862.2100 75, Clinical Chemistry module for clinical use. Predicate Device: iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application, 510O(k) K103544 NAmendment Page 5of 30 === Page 2 =… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132148 | S Health | 2013 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K132148 (Samsung Electronics Co., Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103544.
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. 2013, 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 from 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 patient and should not be shared. 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…
Read the full statement (168 words)
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from 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 patient and should not be shared. 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.
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 as stated in the FDA summary.
https://510kreport.com/device/K130535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130535: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130535
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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