510(k) Report

510(k) · Cleared

Cleared

Prodigy Voice Blood Glucose Monitoring System

K073118510(k) TraditionalCleared Mar 5, 2008121-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

Diagnostic Devices, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Mar 5, 2008 as substantially equivalent to K060467 (Diagnostic Devices, Inc., 2006) after a 121-day review. Its family tree reaches back 2 generations to 2004. 14 later devices descend from it.

Decided
Mar 5, 2008
Review
121 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K042005 (2004). 14 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 4 descendants cleared2009: 1 descendant cleared2010: 4 descendants cleared2014: 2 descendants cleared2015: 2 descendants cleared2016: 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. · 2006200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 3 descendants K060467 · 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 · 2 generations backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
  2. 1 generation backK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
  3. This deviceK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
  4. Descendant · cites it directly · 6 of its ownK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
  5. Descendant · cites it directly · 3 of its ownK122338 Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013
  6. Descendant · 2 generations on · 1 of its ownK141914 Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2015
  7. Descendant · 2 generations on · 1 of its ownK100560 Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp. · 2010
  8. Descendant · 2 generations on · 1 of its ownK093764 SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp. · 2010

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2009: 12010: 42013: 42014: 22015: 22016: 1
2009high 4 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 14 · See all
  • K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009 · cites it directly6descendants
  • K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013 · cites it directly3descendants
  • K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2015 · 2 generations on1descendant
  • K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp. · 2010 · 2 generations on1descendant
  • K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp. · 2010 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K042005Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation2004—
−1K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc.2006—
0 (this device)K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc.2008—
+1K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp.2009—
+1K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC2013—
+2K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd.2015—
+2K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp.2010—
+2K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201040
201340
201420
201520
201610
FIG. 1 — Lineage of K073118, 2004–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K060467Prodigy Blood Glucose Test System
Summary page 1
…Name: Blood Glucose Meter Blood Glucose Test Strips Submitter DIAGNOSTIC DEVICES INC. 510 (k) Number K060467 vii Page 2…
Diagnostic Devices, Inc.2006—

Also cleared against K060467: 1 other device →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp.20096
K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC20133
K090609Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20101
K122340Prodigy ChoiceProdigy Diabetes Care, LLC20130

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 4 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K091815 (Biotest Medical Corp., 2009) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K060467.

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. 2008, 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 Prodigy Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the…

Read the full statement (113 words)

The Prodigy Voice Blood Glucose Monitoring System is intended for use in the

quantitative measurement of glucose in fresh capillary whole blood from the

finger and the following alternative sites: the palm, the forearm, the upper-arm,

the calf and the thigh. It is intended for use by healthcare professionals and

people with diabetes mellitus at home as an aid in monitoring the effectiveness

of diabetes control program. It is not intended for the diagnosis of or screening

for diabetes mellitus.

The alternative site testing in this system can be used only during steady-state

blood glucose conditions.

This system contains a speaking functionality which provides step by step

instructions to aid visually impaired persons.

Indications for use as stated in the FDA summary.

Also cleared against K060467

1 other device cites the same predicate.

  • K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016

More from Diagnostic Devices, Inc.

4 FDA decisions under this applicant name. See the company

  • K090307Ddi Ultrasonic Nebulizer SystemDiagnostic Devices, Inc. · 2009
  • K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
  • K053593ProdigyDiagnostic Devices, Inc. · 2006

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/K073118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073118: Prodigy Voice Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073118

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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