510(k) · Cleared
ClearedEasy Step and Diachex+ Pro Blood Glucose Monitoring Systems
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 Jun 4, 2009 as substantially equivalent to K073492 (Tyson Bioresearch, Inc., 2008) after an 87-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 4, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K964630 (1997). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
- 4 generations backK040848 EZ SmartVip International Wholesalers, Corp. · 2004
- 3 generations backK052818 EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- 2 generations backK062829 Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
- 1 generation backK073492 Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity…Tyson Bioresearch, Inc. · 2008
- This deviceK090629 Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101543 Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK123087 Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio…Tyson Bioresearch, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964630 | Glucometer Elite Blood Glucose Meter | Bayer Corp. | 1997 | — |
| −4 | K040848 | EZ Smart | Vip International Wholesalers, Corp. | 2004 | — |
| −3 | K052818 | EZ Smart-168 Glucose Monitoring System | Tyson Bioresearch, Inc. | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K090629 | Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems | Tyson Bioresearch, Inc. | 2009 | — |
| +1 | K101543 | Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200 | Tyson Bioresearch, Inc. | 2011 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K073492 | Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…Summary page 2…n of results with laboratory methods. 7. PREDICATE DEVICE: Predicate device name(s): DIACHEX + INFINITY Blood Glucose Monitoring System Predicate 510(k) number(s): k073492 Comparison with predicate: This 510(K) amendment addresses the changes of the DIACHEX + INFINITY Blood… | 2008 |
| † | K062829 | Diachex Blood Glucose Monitoring System | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101543 | Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200 | 2011 | 1 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K101543 (Tyson Bioresearch, Inc., 2011) has gone furthest, with 1 descendant of its own.
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?
The Easy Step / DIACHEX+ PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX + PRO Blood Glucose Test Strips are for testing outside the body (in vitro, diagnostic use). The Easy Step / DIACHEX + PRO Blood Glucose Monitoring System is intended for use at home (over the…
Read the full statement (137 words)
The Easy Step / DIACHEX+ PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX + PRO Blood Glucose Test Strips are for testing outside the body (in vitro, diagnostic use). The Easy Step / DIACHEX + PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090629: Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090629
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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