510(k) Report

510(k) · Cleared

Cleared

Supercheck 1 Blood Glucose Monitoring System, Model 6268

K091815510(k) TraditionalCleared Nov 16, 2009151-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

Biotest Medical Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Nov 16, 2009 as substantially equivalent to K073118 (Diagnostic Devices, Inc., 2008) after a 151-day review. Its family tree reaches back 3 generations to 2004. 6 later devices descend from it.

Decided
Nov 16, 2009
Review
151 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K042005 (2004). 6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2010: 3 descendants cleared2014: 1 descendant clearedK042005 · Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 · Taidoc Technology Corporation · 2004K060467 · Prodigy Blood Glucose Test System · Diagnostic Devices, Inc. · 2006K073118 · Prodigy Voice Blood Glucose Monitoring System · Diagnostic Devices, Inc. · 2008200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants K073118 · Prodigy Voice Blood Glucose Monitoring System · Diagnostic Devices, Inc. · 2008K060467 · Prodigy Blood Glucose Test System · Diagnostic Devices, Inc. · 2006K042005 · Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 · Taidoc Technology Corporation · 20040
  1. Root · 3 generations backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
  2. 2 generations backK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
  3. 1 generation backK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
  4. This deviceK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
  5. Descendant · cites it directly · 1 of its ownK100560 Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp. · 2010
  6. Descendant · cites it directly · 1 of its ownK093764 SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp. · 2010
  7. Descendant · 2 generations on · 0 of its ownK133509 Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi…Biotest Medical Corp. · 2014
  8. Descendant · 2 generations on · 0 of its ownK123559 Solusmobile Blood Glucose Managment SystemBiotest Medical Corp. · 2013
  9. Descendant · cites it directly · 0 of its ownK122525 Smartest Glucowise Blood Glucose Monitoring System, and Smartest…Biotest Medical Corp. · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 32013: 22014: 1
2010high 3 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp. · 2010 · cites it directly1descendant
  • K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp. · 2010 · cites it directly1descendant
  • K133509Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring…Biotest Medical Corp. · 2014 · 2 generations on0descendants
  • K123559Solusmobile Blood Glucose Managment SystemBiotest Medical Corp. · 2013 · 2 generations on0descendants
  • K122525Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood…Biotest Medical Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K042005Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation2004—
−2K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc.2006—
−1K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc.2008—
0 (this device)K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp.2009—
+1K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp.2010—
+1K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp.2010—
+2K133509Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose…Biotest Medical Corp.2014—
+2K123559Solusmobile Blood Glucose Managment SystemBiotest Medical Corp.2013—
+1K122525Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise…Biotest Medical Corp.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201320
201410
FIG. 1 — Lineage of K091815, 2004–2014Source: 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
*K073118Prodigy Voice Blood Glucose Monitoring System
Summary page 1
…od Glucose Monitoring System Common/Usual NameBlood Glucose Meter Blood Glucose Test Strips Submitter Diagnostic Devices Inc. 510(k) Number K073118 4. Device Description The SuperCheck I Blood Glucose Monitoring System, Model 6268 consists of a blood glucose meter, blood gluc…
Diagnostic Devices, Inc.2008—

Also cleared against K073118: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp.20101
K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp.20101
K122525Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood…Biotest Medical Corp.20130
K100701Smartest Persona Blood Glucose Test Sytem Model: 6277Biotest Medical Corp.20100

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 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K100560 (Biotest Medical Corp., 2010) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K073118.

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. 2009, this device’s year, is highlighted.

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 SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

Indications for use as stated in the FDA summary.

Also cleared against K073118

3 other devices cite the same predicate.

  • K122340Prodigy ChoiceProdigy Diabetes Care, LLC · 2013
  • K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013
  • K090609Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2010

More from Biotest Medical Corp.

8 FDA decisions under this applicant name. See the company

  • K141351Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring SystemBiotest Medical Corp. · 2015
  • K133509Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring System,Smartest…Biotest Medical Corp. · 2014
  • K123559Solusmobile Blood Glucose Managment SystemBiotest Medical Corp. · 2013
  • K122525Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood Glucose Monitoring…Biotest Medical Corp. · 2013
  • K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp. · 2010

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/K091815 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091815: Supercheck 1 Blood Glucose Monitoring System, Model 6268.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091815

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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