510(k) · Cleared
ClearedJazz Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agamatrix · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 20, 2007 after a 60-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jul 20, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK071393 Jazz Blood Glucose Monitoring SystemAgamatrix · 2007
- Descendant · cites it directly · 9 of its ownK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK131230 Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK150817 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK152365 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK130535 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc. · 2011 · cites it directly9descendants
- K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014 · 2 generations on4descendants
- K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · 3 generations on2descendants
- K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016 · 2 generations on1descendant
- K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071393 | Jazz Blood Glucose Monitoring System | Agamatrix | 2007 | — |
| +1 | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application… | Agamatrix, Inc. | 2011 | — |
| +2 | K131230 | Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application | Philosys, Inc. | 2014 | — |
| +3 | K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2015 | 1 |
| +2 | K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | 2016 | — |
| +2 | K130535 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application | Agamatrix, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Liberty Blood Glucose Monitoring System Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D | 2011 | 9 |
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?
- Of its descendants, K103544 (Agamatrix, Inc., 2011) has gone furthest, with 9 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. 2007, 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?
AgaMatrix JAZZTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ TM…
Read the full statement (263 words)
AgaMatrix JAZZTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix JAZZ TM Blood Glucose Meter is intended for use with AgaMatrix JAZZ TM Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix JAZZ TM Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ TM Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix JAZZTM Control Solutions are intended for use with the AgaMatrix JAZZKM Meter and AgaMatrix JAZZ TM Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071393: Jazz Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071393
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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