510(k) · Cleared
ClearedMajor Iii 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 Feb 29, 2008 as substantially equivalent to K062538 (Diacare Corp., 2007) after a 198-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Feb 29, 2008
- Review
- 198 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. No later device cites it as a predicate yet.
- 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 deviceK072274 Major Iii Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2008
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) | K072274 | Major Iii Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2008 | — |
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 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…tiveness Information * Predicate Device: Claim of Substantial Equivalence (SE) is made to EASY CHECK Blood Gltcose Monitoring System (K062538) * Device Description: Based on an electrochemical biosensor technology and the principle of capilla… | 2007 |
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 11 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.
- 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. 2008, 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 MAJOR III Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary blood from the fingertip. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072274: Major Iii 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/K072274
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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