510(k) · Cleared
ClearedEZ Smart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vip Diagnostics, LLC · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 2, 2005 as substantially equivalent to K040848 (Vip International Wholesalers, Corp., 2004) and 3 other predicates after a 181-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jun 2, 2005
- Review
- 181 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K964630 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964630 | Glucometer Elite Blood Glucose Meter | Bayer Corp. | 1997 | — |
| −1 | K040848 | EZ Smart | Vip International Wholesalers, Corp. | 2004 | — |
| 0 (this device) | K043340 | EZ Smart | Vip Diagnostics, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (4)
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 |
|---|---|---|---|
| * | K040848 | EZ SmartSummary page 2…ite XL with the Elite Test Strips Bayer Elite with the Elite Test Strips 2. Predicate K Number K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite)… | 2004 |
| * | K984006 | Glucometer Elite XL Blood Glucose MeterSummary page 2…Bayer Elite with the Elite Test Strips 2. Predicate K Number K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips)… | 1999 |
| * | K964630 | Glucometer Elite Blood Glucose MeterSummary page 2…ips 2. Predicate K Number K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips) 3. Substantial Equivalence Compar… | 1997 |
| * | K991242 | Glucometer Elite Test StripsSummary page 2…er K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips) 3. Substantial Equivalence Comparison The modifications to th… | 1999 |
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 8 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K040848.
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 EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.
The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043340: EZ Smart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043340
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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