510(k) · Cleared
ClearedGlucometer Elite Test Strips
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 Jun 30, 1999 after a 79-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jun 30, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK991242 Glucometer Elite Test StripsBayer Corp. · 1999
- Descendant · cites it directly · 8 of its ownK040848 EZ SmartVip International Wholesalers, Corp. · 2004
- Descendant · 2 generations on · 6 of its ownK052818 EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- Descendant · 3 generations on · 4 of its ownK062829 Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- Descendant · 4 generations on · 3 of its ownK073492 Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity…Tyson Bioresearch, Inc. · 2008
- Descendant · 5 generations on · 2 of its ownK090629 Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K040848EZ SmartVip International Wholesalers, Corp. · 2004 · cites it directly8descendants
- K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006 · 2 generations on6descendants
- K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006 · 3 generations on4descendants
- K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…Tyson Bioresearch, Inc. · 2008 · 4 generations on3descendants
- K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991242 | Glucometer Elite Test Strips | Bayer Corp. | 1999 | — |
| +1 | K040848 | EZ Smart | Vip International Wholesalers, Corp. | 2004 | — |
| +2 | K052818 | EZ Smart-168 Glucose Monitoring System | Tyson Bioresearch, Inc. | 2006 | — |
| +3 | K062829 | Diachex Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | 2006 | — |
| +4 | K073492 | Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood… | Tyson Bioresearch, Inc. | 2008 | — |
| +5 | K090629 | Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems | Tyson Bioresearch, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 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® Test Strips Named without a submission number |
What descends from it? (10)
3 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, K040848 (Vip International Wholesalers, Corp., 2004) has gone furthest, with 8 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® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and 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/K991242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991242: Glucometer Elite Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991242
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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