510(k) · Cleared
ClearedAP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bestgen Biotech Corp. · CGA Glucose Oxidase, Glucose
Cleared on Mar 13, 2012 as substantially equivalent to K090389 (Bestgen Biotech Corp., 2009) after a 509-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Mar 13, 2012
- Review
- 509 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964630 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
- 3 generations backK043311 Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
- 2 generations backK062538 Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007
- 1 generation backK090389 AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
- This deviceK103116 AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964630 | Glucometer Elite Blood Glucose Meter | Bayer Corp. | 1997 | — |
| −3 | K043311 | Ascensia Elite Diabetes Care System | Bayer Healthcare, LLC | 2004 | — |
| −2 | K062538 | Easy Check Blood Glucose Monitoring System | Diacare Corp. | 2007 | — |
| −1 | K090389 | AP-1000 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2009 | — |
| 0 (this device) | K103116 | AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K090389 | AP-1000 Blood Glucose Monitoring SystemSummary page 4…od Glucose Monitoring System. 5. Substantial Equivalence Informatian A. Predicate device name: AP-1000 Blood Glucose Monitoring System B. Predicate K number: k090389 C. Comparison with predicate: The modified AP-2000, AP-2000multi, AP-2010, AP-2Ol0multi, AP-2020, and AP-2O2Omulti Blood… | 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 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K090389.
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 AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). it is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not…
Read the full statement (1,796 words)
The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). it is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000 Blood Glucose Test Strips must be used with the AP-2000 Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000 Blood Glucose Test Strips must be used the AP-2000 Blood Glucose Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
MAJOR Level I/Level 11Control Solution are for use with AP-2000 meter and AP-2000 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The AP-2000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000multi Blood Glucose Test Strips must be used with the AP-2000multi Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2000multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2000multi Blood Glucose Test Strips must be used the AP-2000multi Blood Glucose Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
MAJOR Level I/Level 11Control Solution is for use with AP-2000mullti meter and AP-2000multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The A17-2010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2010 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2010 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2010 Blood Glucose Test Strips must be used with the AP-2010 Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2010 Blood Glucose Test Strips, are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2010 Blood Glucose Test Strips must be used the AP-2010 Blood Glucose Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
MAJOR Level I/Level 11Control Solution are for use with AP-2010 meter and AP-2010 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The AP-2Ol0multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2Ol0multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2Ol0multi Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2Ol0multi Blood Glucose Test Strips must be used with the AP-2Ol0multi Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2Ol0multi Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2Ol0multi Blood Glucose Test Strips must be used the AP-2Ol0multi Blood Glucose Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
MAJOR Level I/Level 11Control Solution is for use with AP-2Ol0multi meter and AP-2Ol0multi Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The AP-2020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2020 Blood Glucose Monitoring Systems is iiitended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2020 Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2020 Blood Glucose Test Strips must be used with the AP-2020 Meter. it is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2020 Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2020 Blood Glucose Test Strips must be used the AP-2020 Blood Glucose Meter. It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
MAJOR Level I/Level 11Control Solution are for use with AP-2020 meter and.AP-2020 Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The AP-2OZ0multi Blood Glucose monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2O2Omulti Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2O2Omulti Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2O2Omulti Blood Glucose Test Strips must be used with the AP-2Omulti Meter. It is intended for multi-patient use in 6 professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The AP-2O2Omulti Blood Glucose Test Strips are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. AP-2O2Omulti Blood Glucose Test Strips must be used the AP-2O2Omulti Blood Glucose Meter. It is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use, auto-disabling lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
MAJOR Level I/Level 11Control Solution is for use with AP-2Omulti meter and AP-2O2Oimulti Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103116: AP-2000, AP-2010, and AP-2020 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/K103116
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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