510(k) · Cleared

Cleared

Prodigy Blood Glucose Test System

K060467510(k) TraditionalCleared Jul 13, 2006140-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 Jul 13, 2006 as substantially equivalent to K042005 (Taidoc Technology Corporation, 2004) after a 140-day review. Its family tree reaches back 1 generation to 2004. 17 later devices descend from it.

Decided: Jul 13, 2006
Review: 140 days
Class: Class II
Product code: NBW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042005 (2004). 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
This deviceK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
Descendant · cites it directly · 14 of its ownK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
Descendant · 2 generations on · 6 of its ownK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
Descendant · 2 generations on · 3 of its ownK122338 Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013
Descendant · cites it directly · 1 of its ownK160038 UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016
Descendant · 3 generations on · 1 of its ownK141914 Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2015

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008high 4 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all

K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008 · cites it directly14descendants
K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009 · 2 generations on6descendants
K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013 · 2 generations on3descendants
K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016 · cites it directly1descendant
K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2015 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042005	Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222	Taidoc Technology Corporation	2004	—
0 (this device)	K060467	Prodigy Blood Glucose Test System	Diagnostic Devices, Inc.	2006	—
+1	K073118	Prodigy Voice Blood Glucose Monitoring System	Diagnostic Devices, Inc.	2008	—
+2	K091815	Supercheck 1 Blood Glucose Monitoring System, Model 6268	Biotest Medical Corp.	2009	—
+2	K122338	Preferred Blood Glucose Monitoring System	Prodigy Diabetes Care, LLC	2013	—
+1	K160038	UniStrip1 Generic Blood Glucose Test Strips	Ok Biotech Co., Ltd.	2016	—
+3	K141914	Prodigy Autocode Eject Blood Glucose Monitoring System	Ok Biotech Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	4	0
2013	4	0
2014	2	0
2015	2	0
2016	2	0
2017	1	0

FIG. 1 — Lineage of K060467, 2004–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K042005	Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 Summary page 1 …system and Quality Control Material Safety and Effective Information Predicate Device: Claim of Substantial Equivalence (SE) is made to TaiDoc Technology Corporation. K042005, Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose Test Systems. Indications for Use: The Prodigy Blood Glucos…	Taidoc Technology Corporation	2004	—

Also cleared against K042005: 2 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K073118	Prodigy Voice Blood Glucose Monitoring System	Diagnostic Devices, Inc.	2008	14
K160038	UniStrip1 Generic Blood Glucose Test Strips	Ok Biotech Co., Ltd.	2016	1

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?

Its one ancestor has no recall.
Of its descendants, K073118 (Diagnostic Devices, Inc., 2008) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K042005.

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

2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007high 465 (2021) · low 85 (2007)2026

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

Recalls per year · NBW

1in 2025

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

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

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 Prodigy Blood Glucose Test System is intended to be used for the quantitative

measurement of glucose in capillary whole blood from the fingertip and palm. 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, and not intended for use on

neonates.

The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the

Prodigy Glucose Control Solutions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060467 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060467: Prodigy Blood Glucose Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060467

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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