510(k) · Cleared
ClearedEasy Check Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diacare Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 30, 2007 as substantially equivalent to K043311 (Bayer Healthcare, LLC, 2004) after a 244-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Apr 30, 2007
- Review
- 244 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964630 (1997). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
- 1 generation backK043311 Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
- This deviceK062538 Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007
- Descendant · cites it directly · 4 of its ownK090389 AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK103230 AP-3000 Blood Glucose Monitoring System, Major Glucose Control…Bestgen Biotech Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK103116 AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK103044 AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose…Bestgen Biotech Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK100437 AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major…Bestgen Biotech Corp. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009 · cites it directly4descendants
- K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · 2 generations on0descendants
- K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012 · 2 generations on0descendants
- K103044AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · 2 generations on0descendants
- K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964630 | Glucometer Elite Blood Glucose Meter | Bayer Corp. | 1997 | — |
| −1 | K043311 | Ascensia Elite Diabetes Care System | Bayer Healthcare, LLC | 2004 | — |
| 0 (this device) | K062538 | Easy Check Blood Glucose Monitoring System | Diacare Corp. | 2007 | — |
| +1 | K090389 | AP-1000 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2009 | — |
| +2 | K103230 | AP-3000 Blood Glucose Monitoring System, Major Glucose Control Solution | Bestgen Biotech Corp. | 2012 | — |
| +2 | K103116 | AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2012 | — |
| +2 | K103044 | AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control… | Bestgen Biotech Corp. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K043311 | Ascensia Elite Diabetes Care SystemSummary page 1…ABETES CARE SYSTEM Predicate Device Name and 5 10(k) Number: _ __ __ __ __ _ __ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ k 04 3 3 1 1 Description of Device: The EASY CHECK Blood Glucose Monitoring System is designed to provide an easy, accurate m… | 2004 |
What descends from it? (6)
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 10 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090389 (Bestgen Biotech Corp., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K043311.
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. 2007, 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 EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or…
Read the full statement (122 words)
The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The EASY CHECK Control Solution is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the EASY CHECK Blood Glucose Monitor System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062538: Easy Check 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/K062538
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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