510(k) · Cleared
ClearedMEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · CGA Glucose Oxidase, Glucose
Cleared on May 7, 2015 as substantially equivalent to K120448 (Apex BioTechnology Corp., 2012) after a 127-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- May 7, 2015
- Review
- 127 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101204 (2011). No later device cites it as a predicate yet.
- Root · 2 generations backK101204 Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2…Apex BioTechnology Corp. · 2011
- 1 generation backK120448 Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring…Apex BioTechnology Corp. · 2012 · Recalled
- This deviceK143750 MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose…Apex BioTechnology Corp. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101204 | Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control… | Apex BioTechnology Corp. | 2011 | — |
| −1 | K120448 | Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System… | Apex BioTechnology Corp. | 2012 | 1 |
| 0 (this device) | K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring… | Apex BioTechnology Corp. | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | K120448 | Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood…Summary page 5…se Monitoring System Classification Glucose test system, 21 CFR 862.1345, Class 1l Product Codes CGA, NBW Predicate Devices MEG-2B Blood Glucose Monitoring System (k120448) MEG-2B Pro Blood Glucose Monitoring System (k120448) Device Description The MEG-2B Blood Glucose Monitoring System consists of… | 2012 |
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 4 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucosc in [resh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the…
Read the full statement (226 words)
The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucosc in [resh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabeles or for nconatal usc.
The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucosc Test Strip, is intended for the quantitative measurcment of glucosc in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucosc is not changing rapidly). This sysicm is indicated for multiple-paticnt usc in profcssional healthcare scitings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for tesling outside the body (in vitro diagnostic usc). It is not indicated for the diagnosis or screcning of diabetes or for neonatal use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143750: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose 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/K143750
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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