510(k) · Cleared
ClearedGmate Smart Blood Glucose Monitoring System, Gmate Smart Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philosys, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 4, 2014 as substantially equivalent to K103544 (Agamatrix, Inc., 2011) after a 461-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 4, 2014
- Review
- 461 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. 4 later devices descend from it, 2 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 deviceK131230 Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK150817 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK172723 Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK163159 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK150299 Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · cites it directly2descendants
- K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd. · 2018 · 2 generations on0descendants
- K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2017 · 2 generations on0descendants
- K150299Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc. · 2015 · 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) | K131230 | Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application | Philosys, Inc. | 2014 | — |
| +1 | K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2015 | 1 |
| +2 | K172723 | Dario LC Blood Glucose Monitoring System | Labstyle Innovation, Ltd. | 2018 | — |
| +2 | K163159 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2017 | — |
| +1 | K150299 | Gmate SMART Blood Glucose Monitoring System | Philosys, Inc. | 2015 | — |
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 |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DSummary page 6…510(k) SUMMARY (As required by 21.CFR.807.92) Predicate Device: We claim substantial equivalence to: 1) K103544 – AgaMatrix, Inc. iBGStar System. Device Description: The Gmate® SMART Blood Glucose Monitoring System is intended to be… | 2011 |
What descends from it? (4)
2 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 19 years and passes through 5 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, K150817 (Labstyle Innovations, Ltd., 2015) has gone furthest, with 2 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. 2014, 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 Gmate® SMART Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)…
Read the full statement (265 words)
The Gmate® SMART Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Gmate® SMART should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).
The Gmate® Blood Glucose Test Strips are for use with the GMATE® SMART Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131230: Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131230
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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