510(k) · Cleared
ClearedAP-1000 Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bestgen Biotech Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 14, 2009 as substantially equivalent to K062538 (Diacare Corp., 2007) after a 147-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 14, 2009
- Review
- 147 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964630 (1997). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
- 2 generations backK043311 Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
- 1 generation backK062538 Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007
- This deviceK090389 AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
- Descendant · cites it directly · 0 of its ownK103230 AP-3000 Blood Glucose Monitoring System, Major Glucose Control…Bestgen Biotech Corp. · 2012
- Descendant · cites it directly · 0 of its ownK103116 AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012
- Descendant · cites it directly · 0 of its ownK103044 AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose…Bestgen Biotech Corp. · 2012
- Descendant · cites it directly · 0 of its ownK100437 AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major…Bestgen Biotech Corp. · 2012
Most influential descendants
Showing 4 of 4 · See all- K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · cites it directly0descendants
- K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012 · cites it directly0descendants
- K103044AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · cites it directly0descendants
- K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964630 | Glucometer Elite Blood Glucose Meter | Bayer Corp. | 1997 | — |
| −2 | K043311 | Ascensia Elite Diabetes Care System | Bayer Healthcare, LLC | 2004 | — |
| −1 | K062538 | Easy Check Blood Glucose Monitoring System | Diacare Corp. | 2007 | — |
| 0 (this device) | K090389 | AP-1000 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2009 | — |
| +1 | K103230 | AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution | Bestgen Biotech Corp. | 2012 | — |
| +1 | K103116 | AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2012 | — |
| +1 | K103044 | AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control… | Bestgen Biotech Corp. | 2012 | — |
| +1 | K100437 | AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control… | Bestgen Biotech Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 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 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 |
|---|---|---|---|
| * | K062538 | Easy Check Blood Glucose Monitoring SystemSummary page 1…EASY CHECK Blood Claim of Substantial Equivalence (SE) is made to Glucose Monitoring System (K062538)… | 2007 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103230 | AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution | 2012 | 0 |
| K103116 | AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System | 2012 | 0 |
| K103044 | AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control Solution | 2012 | 0 |
| K100437 | AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control Solution | 2012 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K103230 (Bestgen Biotech Corp., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062538.
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. 2009, 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 AP-1000 Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the…
Read the full statement (277 words)
The AP-1000 Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, 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-1000 Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-.1 000 Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The AP-1000 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. AP-1000 Blood Glucose Test Strips must be used with the AP-1000 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
MAJOR Level I/Level II Control Solution are for use with the AP-1000 meter and AP-1000 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/K090389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090389: AP-1000 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/K090389
Report an extraction error
Are you the manufacturer?
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