510(k) · Cleared
ClearedMeg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control Solution
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 Aug 31, 2011 after a 488-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Aug 31, 2011
- Review
- 488 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK101204 Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2…Apex BioTechnology Corp. · 2011
- Descendant · cites it directly · 1 of its ownK120448 Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring…Apex BioTechnology Corp. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK143750 MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose…Apex BioTechnology Corp. · 2015
Most influential descendants
Showing 2 of 2 · See all- K120448Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood…Apex BioTechnology Corp. · 2012 · cites it directly1descendant
- K143750MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | — | GlucoSure STAR meter and test strips Named without a submission number | |
| * | — | Contrex Plus glucose control solutions Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120448 | Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood… | 2012 | 1 |
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?
- Of its descendants, K120448 (Apex BioTechnology Corp., 2012) has gone furthest, with 1 descendant 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. 2011, 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?
MEG-2 Blood Glucose Monitoring System: The MEG-2 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. Testing is done outside the body (In Vitro diagnostic use). 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…
Read the full statement (410 words)
MEG-2 Blood Glucose Monitoring System:
The MEG-2 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. Testing is done outside the body (In Vitro diagnostic use). 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. Alternative site testing can be used only during steady-state blood glucose conditions.
MEG-2 Blood Glucose Test Strips:
The MEG-2 Blood Glucose Test Strips are to be used with the MEG-2 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). 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.
MEG-2 Glucose Control Solution:
The MEG-2 Glucose Control Solutions are used with the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
MEG-2 Multi Blood Glucose Monitoring System:
The MEG-2 Multi 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. Testing is done outside the body (In Vitro diagnostic use). 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. Alternative site testing can be used only during steady-state blood glucose conditions.
MEG-2 Multi Blood Glucose Test Strips:
The MEG-2 Multi Blood Glucose Test Strips are to be used with the MEG-2 Multi Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101204: Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101204
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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