510(k) · Cleared
ClearedBGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 4, 2022 as substantially equivalent to K202885 (Apex BioTechnology Corp., 2021) after a 263-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Nov 4, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K011233 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
- 7 generations backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
- 6 generations backK073648 Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008
- 5 generations backK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
- 4 generations backK113208 Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012
- 3 generations backK141036 BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015
- 2 generations backK170267 BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2017
- 1 generation backK202885 GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2021
- This deviceK220421 BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose…Apex BioTechnology Corp. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011233 | Modification to Glucosure BGM System, Model 221100 | Apex BioTechnology Corp. | 2001 | 1 |
| −7 | K062799 | Gluco Track Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2007 | — |
| −6 | K073648 | Glucosure Star Blood Glucose Monitoring System, Model AS90000E1 | Apex BioTechnology Corp. | 2008 | — |
| −5 | K102816 | Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips | Apex BioTechnology Corp. | 2011 | — |
| −4 | K113208 | Gal-1A Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2012 | — |
| −3 | K141036 | BGM009 Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2015 | — |
| −2 | K170267 | BGM009 Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2017 | — |
| −1 | K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2021 | — |
| 0 (this device) | K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring… | Apex BioTechnology Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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 |
|---|---|---|---|
| * | K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemSummary page 5…tem Classification Glucose test system, 21 CFR 862.1345, Class II Product Codes NBW Predicate GlucoSure HT Plus Blood Glucose Monitoring System (K202885) Devices Device BGM039 brand of Blood Glucose Monitoring System is designed to have two Description variation mod… | 2021 |
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 21 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
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. 2022, 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 BGM039 Blood Glucose Monitoring System is comprised of the BGM039 Blood Glucose Meter and the BGM039 Blood Glucose Test Strips. The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood sanlples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing…
Read the full statement (247 words)
The BGM039 Blood Glucose Monitoring System is comprised of the BGM039 Blood Glucose Meter and the BGM039 Blood Glucose Test Strips.
The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood sanlples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be. used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The BGM039 Link Blood Glucose Monitoring System is comprised of the BGM039 Link Blood Glucose Meter and the BGM039 Blood Glucose Test Strips.
The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingeltips, forearm, or palm. Altemative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220421: BGM039 Blood Glucose Monitoring System, BGM039 Link 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/K220421
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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