510(k) · Cleared
ClearedEZ Scan Plus 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 Mar 25, 2008 as substantially equivalent to K052818 (Tyson Bioresearch, Inc., 2006) after a 208-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 25, 2008
- Review
- 208 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. No later device cites it as a predicate yet.
- 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 deviceK072441 EZ Scan Plus Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2008
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) | K072441 | EZ Scan Plus Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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…f 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. EZ Scan Plus Blood Glucose Monitoring System in this submission… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 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.
- 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. 2008, 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 EZ Scan Plus Blood Glucose Test Strips are used with the EZ Scan Plus Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood drawn from the fingertip and the alternate sites: palm and forearm. The EZ Scan Plus Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Scan Plus 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072441: EZ Scan Plus Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072441
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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