510(k) · Cleared
ClearedGlucometer Elite Blood Glucose Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CGA Glucose Oxidase, Glucose
Cleared on Feb 10, 1997 after an 83-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Feb 10, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 6 citing it directly.
- This deviceK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
- Descendant · cites it directly · 9 of its ownK043311 Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
- Descendant · cites it directly · 8 of its ownK040848 EZ SmartVip International Wholesalers, Corp. · 2004
- Descendant · 2 generations on · 6 of its ownK062538 Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007
- Descendant · 2 generations on · 6 of its ownK052818 EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- Descendant · 3 generations on · 4 of its ownK090389 AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004 · cites it directly9descendants
- K040848EZ SmartVip International Wholesalers, Corp. · 2004 · cites it directly8descendants
- K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007 · 2 generations on6descendants
- K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006 · 2 generations on6descendants
- K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964630 | Glucometer Elite Blood Glucose Meter | Bayer Corp. | 1997 | — |
| +1 | K043311 | Ascensia Elite Diabetes Care System | Bayer Healthcare, LLC | 2004 | — |
| +1 | K040848 | EZ Smart | Vip International Wholesalers, Corp. | 2004 | — |
| +2 | K062538 | Easy Check Blood Glucose Monitoring System | Diacare Corp. | 2007 | — |
| +2 | K052818 | EZ Smart-168 Glucose Monitoring System | Tyson Bioresearch, Inc. | 2006 | — |
| +3 | K090389 | AP-1000 Blood Glucose Monitoring System | Bestgen Biotech Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | — | GLUCOMETER ELITE® Blood Glucose Meter Named without a submission number |
What descends from it? (23)
See all 236 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?
- Of its descendants, K043311 (Bayer Healthcare, LLC, 2004) has gone furthest, with 9 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.*
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/K964630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964630: Glucometer Elite Blood Glucose Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964630
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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