510(k) · Cleared
ClearedBetachek Glucose Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Diagnostic Products · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Mar 24, 2009 as substantially equivalent to K943503 (Chem-Elec, Inc., 1996) after a 966-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 24, 2009
- Review
- 966 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943503 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK943503 Chemcard Glucose TestChem-Elec, Inc. · 1996
- This deviceK062187 Betachek Glucose TestNational Diagnostic Products · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943503 | Chemcard Glucose Test | Chem-Elec, Inc. | 1996 | — |
| 0 (this device) | K062187 | Betachek Glucose Test | National Diagnostic Products | 2009 | — |
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 |
|---|---|---|---|
| * | K943503 | Chemcard Glucose TestSummary page 1…e) 3. Predicate Device Name: Chemcard Glucose Test Manufacturer: CHEM-ELEC, INC 51 0 (K) Number: K943503. 4. Description of the Device Reagent test principle - glucose oxidase 5. Intended Use Betachek Blood Glucose Test is a test i… | 1996 |
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?
- Its one ancestor has no recall.
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?
Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick. Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result…
Read the full statement (184 words)
Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.
Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.
Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.
This test can not be used to screen or diagnose diabetes.
It should not be used for children or by individuals who are diabetic or pregnant.
This test is only intended for individual use at home.
It is not for use as part of a screening program in a healthcare setting or any other setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062187: Betachek Glucose Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062187
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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