510(k) · Cleared
ClearedDiachex Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyson Bioresearch, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 10, 2006 as substantially equivalent to K052818 (Tyson Bioresearch, Inc., 2006) after a 20-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Oct 10, 2006
- Review
- 20 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. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
- 2 generations backK040848 EZ SmartVip International Wholesalers, Corp. · 2004
- 1 generation backK052818 EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- This deviceK062829 Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK073492 Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity…Tyson Bioresearch, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK090629 Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK101543 Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK123087 Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio…Tyson Bioresearch, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…Tyson Bioresearch, Inc. · 2008 · cites it directly3descendants
- K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009 · 2 generations on2descendants
- K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011 · 3 generations on1descendant
- K123087Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood…Tyson Bioresearch, Inc. · 2013 · 4 generations on0descendants
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 | K040848 | EZ Smart | Vip International Wholesalers, Corp. | 2004 | — |
| −1 | K052818 | EZ Smart-168 Glucose Monitoring System | Tyson Bioresearch, Inc. | 2006 | — |
| 0 (this device) | K062829 | Diachex Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | 2006 | — |
| +1 | K073492 | Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood… | Tyson Bioresearch, Inc. | 2008 | — |
| +2 | K090629 | Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems | Tyson Bioresearch, Inc. | 2009 | — |
| +3 | K101543 | Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200 | Tyson Bioresearch, Inc. | 2011 | — |
| +4 | K123087 | Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800… | Tyson Bioresearch, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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 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 |
|---|---|---|---|
| * | K052818 | EZ Smart-168 Glucose Monitoring SystemSummary page 2…n of results with laboratory methods. 7. PREDICATE DEVICE: Predicate device name(s): EZ Smart - 168 Blood Glucose Monitoring System Predicate 510(k) number(s): k052818 Comparison with predicate: The Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System in this submission is eq… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073492 | Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose… | 2008 | 3 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073492 (Tyson Bioresearch, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K052818.
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.
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 DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels for better glucose control among diabetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062829: Diachex 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/K062829
Report an extraction error
Are you the manufacturer?
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