510(k) · Cleared
Recalled · Class II · 2019Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control
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 Apr 6, 2012 as substantially equivalent to K101204 (Apex BioTechnology Corp., 2011) after a 52-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 6, 2012
- Review
- 52 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101204 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK101204 Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2…Apex BioTechnology Corp. · 2011
- This deviceK120448 Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring…Apex BioTechnology Corp. · 2012
- Descendant · cites it directly · 0 of its ownK143750 MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose…Apex BioTechnology Corp. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143750MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101204 | Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control… | Apex BioTechnology Corp. | 2011 | — |
| 0 (this device) | K120448 | Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System… | Apex BioTechnology Corp. | 2012 | — |
| +1 | K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring… | Apex BioTechnology Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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 |
|---|---|---|---|
| * | K101204 | Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control SolutionSummary page 1…assayed), Class 1, 21 CFR 862.1660, Product Codes: CGA, NBW; JJX Predicate Device: MEG-2 Blood Glucose Monitoring System (k101204) MEG-2 Multi Blood Glucose Monitoring System (k101204) MEG-2 Blood Glucose… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2019 | Class II | Z-0513-2020 | Packaging process control | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K143750 (Apex BioTechnology Corp., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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-2B3 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The…
Read the full statement (333 words)
The MEG-2B3 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The MEG-2B3 Blood Glucose Test Strips are to be used with the MEG-2B3 Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The MEG-2B3 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is indicated to be use for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The MEG-2B3 Pro Blood Glucose Test Strips are td be used with the MEG-2B3 Pro Blood Glucose Meter; it measures glucose in capillar whole blood taken from a fingertip; palm, or forearm. It is indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing device.
The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a-known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120448: Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120448
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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