510(k) · Cleared
ClearedBGM014 Blood Glucose Monitoring System, BGM014 Pro 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 Dec 23, 2016 as substantially equivalent to K131750 (Apex BioTechnology Corp., 2014) after a 228-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 23, 2016
- Review
- 228 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011233 (2001). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
- 5 generations backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
- 4 generations backK073648 Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008
- 3 generations backK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
- 2 generations backK113208 Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012
- 1 generation backK131750 Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014
- This deviceK161299 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose…Apex BioTechnology Corp. · 2016
- Descendant · cites it directly · 0 of its ownK222234 GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
- Descendant · cites it directly · 0 of its ownK182992 BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011233 | Modification to Glucosure BGM System, Model 221100 | Apex BioTechnology Corp. | 2001 | 1 |
| −5 | K062799 | Gluco Track Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2007 | — |
| −4 | K073648 | Glucosure Star Blood Glucose Monitoring System, Model AS90000E1 | Apex BioTechnology Corp. | 2008 | — |
| −3 | K102816 | Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips | Apex BioTechnology Corp. | 2011 | — |
| −2 | K113208 | Gal-1A Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2012 | — |
| −1 | K131750 | Autosure HT Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2014 | — |
| 0 (this device) | K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring… | Apex BioTechnology Corp. | 2016 | — |
| +1 | K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022 | — |
| +1 | K182992 | BGM014 Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K131750 | Autosure HT Blood Glucose Monitoring SystemSummary page 5…yed and unassayed), Class I, 21 CFR 862.1660 Product Codes: NBW, LFR, JJX Predicate Devices: AutoSure HT Blood Glucose Monitoring System (k131750) Device Description: The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of b… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K222234 (Apex BioTechnology Corp., 2022) has gone furthest, with 0 descendants of its own.
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. 2016, 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 BGM014 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of…
Read the full statement (323 words)
The BGM014 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. 1t is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.
The Contrex Plus 5 glucose control solution is used with the BGM014 Meter and BGMO014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.
The BGMO014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in venous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The BGMO014 Pro Blood Glucose Monitoring System is comprised of the BGMO014 Pro Blood Glucose Meter and BGMO014 Pro Blood Glucose Test Strip.
The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Meter and BGMO014 Pro Test Strip, Lo verify that the meter and test strip are working together properly and that the test is performing correctly.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro 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/K161299
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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