510(k) Report

510(k) · Cleared

Cleared

EZ Smart

K040848510(k) TraditionalCleared Aug 11, 2004132-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vip International Wholesalers, Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Aug 11, 2004 as substantially equivalent to K964630 (Bayer Corp., 1997) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1997. 8 later devices descend from it.

Decided
Aug 11, 2004
Review
132 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K964630 (1997). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2005: 1 descendant cleared2006: 2 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant clearedK964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 19970+5
  1. Root · 1 generation backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
  2. This deviceK040848 EZ SmartVip International Wholesalers, Corp. · 2004
  3. Descendant · cites it directly · 6 of its ownK052818 EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
  4. Descendant · 2 generations on · 4 of its ownK062829 Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
  5. Descendant · 3 generations on · 3 of its ownK073492 Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity…Tyson Bioresearch, Inc. · 2008
  6. Descendant · 4 generations on · 2 of its ownK090629 Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009
  7. Descendant · 5 generations on · 1 of its ownK101543 Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22008: 22009: 12011: 12013: 1
2005high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006 · cites it directly6descendants
  • K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006 · 2 generations on4descendants
  • K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…Tyson Bioresearch, Inc. · 2008 · 3 generations on3descendants
  • K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009 · 4 generations on2descendants
  • K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964630Glucometer Elite Blood Glucose MeterBayer Corp.1997—
0 (this device)K040848EZ SmartVip International Wholesalers, Corp.2004—
+1K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc.2006—
+2K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc.2006—
+3K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood…Tyson Bioresearch, Inc.2008—
+4K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc.2009—
+5K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200820
200910
201110
201310
FIG. 1 — Lineage of K040848, 1997–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K964630Glucometer Elite Blood Glucose Meter
Summary page 2
…ICE 1. Predicate device name Bayer Elite with the Elite Test Strips 2. Predicate K Number K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips) 3. Substantial Equivalence Comparison I…
Bayer Corp.1997—
*K991242Glucometer Elite Test Strips
Summary page 2
…name Bayer Elite with the Elite Test Strips 2. Predicate K Number K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips) 3. Substantial Equivalence Comparison Item Predicate Devi…
Bayer Corp.1999—

Also cleared against K964630: 5 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc.20066
K043340EZ SmartVip Diagnostics, LLC20050

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K052818 (Tyson Bioresearch, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K964630.

How does its category compare?

All NBW devices

NBW 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

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure

Glucose (sugar) in 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.

Indications for use as stated in the FDA summary.

Also cleared against K964630

5 other devices cite the same predicate.

  • K061234Glucoplus Blood Glucose Monitoring SystemGlucoplus, Inc. · 2006
  • K0502243TEST Glucose Monitoring SystemNeuero Engineering, Inc. · 2005
  • K043340EZ SmartVip Diagnostics, LLC · 2005
  • K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
  • K991480Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc. · 1999

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K040848 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040848: EZ Smart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040848

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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