510(k) · Cleared
ClearedGmate Origin Blood Glucose Monitoring System
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 Dec 1, 2015 as substantially equivalent to K083468 (I-Sens, Inc., 2009) after a 165-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Dec 1, 2015
- Review
- 165 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 2 generations backK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- 1 generation backK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- This deviceK151658 Gmate Origin Blood Glucose Monitoring SystemPhilosys, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −2 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| −1 | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or… | I-Sens, Inc. | 2009 | — |
| 0 (this device) | K151658 | Gmate Origin Blood Glucose Monitoring System | Philosys, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…Summary page 4…II 21 CFR 862.1345 Chemistry (75) Predicate Device: We claim substantial equivalence to: 1) K083468 – I-SENS, Inc. CareSens N Blood Glucose Monitoring System Gmate® Origin 510(k) Summary… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 11 other devices also cite its predicate K083468.
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. 2015, 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® Origin 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® Origin Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Gmate® Origin Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic…
Read the full statement (164 words)
The Gmate® Origin 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®
Origin Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® Origin 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 Gmate® Origin
Glucose Monitoring System 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® Origin Blood Glucose Meter to quantitatively
measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm,
thigh or calf.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151658: Gmate Origin Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151658
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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