510(k) · Cleared
ClearedGLB Benecheck Premium Glu Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Life Biotechnology Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 22, 2013 as substantially equivalent to K053529 (Lifescan, Inc., 2006) after a 417-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Nov 22, 2013
- Review
- 417 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053529 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK053529 Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 2006
- This deviceK123090 GLB Benecheck Premium Glu Monitoring SystemGeneral Life Biotechnology Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | — |
| 0 (this device) | K123090 | GLB Benecheck Premium Glu Monitoring System | General Life Biotechnology Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring SystemSummary page 3…nitoring System is substantially equivalent to the predicate device noted below: Device Name: OneTouch® Ultra2 Blood Glucose Monitoring System 5 10k No.: k053529; Device Company: LifeScan, Inc. Summary of Device Similarities and Differences The predicate device OneTouch® Ultra… | 2006 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K053529.
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 BeneCheck™ Premium GLU Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm and forearm. The BeneCheck™ Premium GLU Monitoring System is intended to be used by a single person and should not be shared. The BeneCheck™ Premium GLU Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes…
Read the full statement (395 words)
The BeneCheck™ Premium GLU Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm and forearm. The BeneCheck™ Premium GLU Monitoring System is intended to be used by a single person and should not be shared. The BeneCheck™ Premium GLU 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 a diabetes control program.
The BeneCheck™ Premium GLU Monitoring System should not be used for the diagnosis of, or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The BeneCheck™ Premium GLU Test Strips are for use with the BeneCheck™ Premium GLU Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The BeneCheck™ Premium GLU Control Solutions are for use with the BeneCheck™ Premium GLU Meter and BeneCheck™ Premium GLU Test Strips to verify that the meters and test strips are working together properly and that the test performs properly.
The BeneCheck™ Premium PRO GLU Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm and forearm. The BeneCheck™ Premium PRO GLU Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of a diabetes control program. The system should only be used with single-use, auto-disabling lancing devices.
The BeneCheck™ Premium PRO GLU Monitoring System should not be used for the diagnosis of, or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The BeneCheck™ Premium PRO GLU Test Strips are for use with the BeneCheck™ Premium GLU PRO Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
The BeneCheck™ Premium PRO GLU Control Solutions are for use with the BeneCheck™ Premium PRO GLU Meter and BeneCheck™ Premium PRO GLU Test Strips to verify that the meters and test strips are working together properly and that the test performs properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123090: GLB Benecheck Premium Glu Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123090
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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