510(k) Report

510(k) · Cleared

Cleared

EZ Smart-168 Glucose Monitoring System

K052818510(k) TraditionalCleared Jun 16, 2006255-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

Tyson Bioresearch, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jun 16, 2006 as substantially equivalent to K040848 (Vip International Wholesalers, Corp., 2004) after a 255-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.

Decided
Jun 16, 2006
Review
255 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K964630 (1997). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2008: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant clearedK964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 1997K040848 · EZ Smart · Vip International Wholesalers, Corp. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K040848 · EZ Smart · Vip International Wholesalers, Corp. · 2004K964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 19970+5
  1. Root · 2 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
  2. 1 generation backK040848 EZ SmartVip International Wholesalers, Corp. · 2004
  3. This deviceK052818 EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
  4. Descendant · cites it directly · 4 of its ownK062829 Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006
  5. Descendant · 2 generations on · 3 of its ownK073492 Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity…Tyson Bioresearch, Inc. · 2008
  6. Descendant · 3 generations on · 2 of its ownK090629 Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009
  7. Descendant · 4 generations on · 1 of its ownK101543 Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011
  8. Descendant · 5 generations on · 0 of its ownK123087 Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio…Tyson Bioresearch, Inc. · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22009: 12011: 12013: 1
2006high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2006 · cites it directly4descendants
  • K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…Tyson Bioresearch, Inc. · 2008 · 2 generations on3descendants
  • K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc. · 2009 · 3 generations on2descendants
  • K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc. · 2011 · 4 generations on1descendant
  • K123087Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood…Tyson Bioresearch, Inc. · 2013 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964630Glucometer Elite Blood Glucose MeterBayer Corp.1997—
−1K040848EZ SmartVip International Wholesalers, Corp.2004—
0 (this device)K052818EZ Smart-168 Glucose Monitoring SystemTyson Bioresearch, Inc.2006—
+1K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc.2006—
+2K073492Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood…Tyson Bioresearch, Inc.2008—
+3K090629Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsTyson Bioresearch, Inc.2009—
+4K101543Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200Tyson Bioresearch, Inc.2011—
+5K123087Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800…Tyson Bioresearch, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200820
200910
201110
201310
FIG. 1 — Lineage of K052818, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K040848EZ Smart
Summary page 1
…Predicate Device: Claim of Substantial Equivalence (SE) is made to VIP International Wholesalers, Corp. -- EZSM4RTBlood Glucose Monitoring System (K040848). * Device Description: Based on an electrochemical biosensor technology and the principle of capillary acti…
Vip International Wholesalers, Corp.2004—

Also cleared against K040848: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K062829Diachex Blood Glucose Monitoring SystemTyson Bioresearch, Inc.20064
K072441EZ Scan Plus Blood Glucose Monitoring SystemTyson Bioresearch, Inc.20080

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 7.5 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K062829 (Tyson Bioresearch, Inc., 2006) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K040848.

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-168 Blood Glucose Test Strips are used with the EZ Smart-168 Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart-168 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels in persons with diabetes.

Indications for use as stated in the FDA summary.

Also cleared against K040848

1 other device cites the same predicate.

  • K043340EZ SmartVip Diagnostics, LLC · 2005

More from Tyson Bioresearch, Inc.

13 FDA decisions under this applicant name. See the company

  • K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2018
  • K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2018
  • K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc. · 2017
  • K123087Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood Glucose Monitoring…Tyson Bioresearch, Inc. · 2013
  • K112916Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring SystemTyson Bioresearch, Inc. · 2012

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/K052818 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052818: EZ Smart-168 Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052818

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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