510(k) Report

510(k) · Cleared

Cleared

G4, Model Igm-0004

K051651510(k) TraditionalCleared Apr 14, 2006297-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

U. S. Diagnostics, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Apr 14, 2006 as substantially equivalent to K024194 (Lifescan, Inc., 2003) and 2 other predicates after a 297-day review. Its family tree reaches back 2 generations to 1995.

Decided
Apr 14, 2006
Review
297 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K942455 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestorK942455 · Lifescan Surestep Blood Glucose Monitoring System · Lifescan, Inc. · 1995K984261 · Surestep Blood Glucose Monitoring System · Lifescan, Inc. · 19991996199820002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K984261 · Surestep Blood Glucose Monitoring System · Lifescan, Inc. · 1999K942455 · Lifescan Surestep Blood Glucose Monitoring System · Lifescan, Inc. · 19950
  1. Root · 2 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
  2. 1 generation backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
  3. This deviceK051651 G4, Model Igm-0004U. S. Diagnostics, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K942455Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc.1995—
−1K984261Surestep Blood Glucose Monitoring SystemLifescan, Inc.1999—
0 (this device)K051651G4, Model Igm-0004U. S. Diagnostics, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
FIG. 1 — Lineage of K051651, 1995–2006Source: 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? (3)

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
*K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems
Summary page 2
…y LifeScan, Inc. Conclusion: The G4 TM Blood Glucose Monitoring System is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP®…
Lifescan, Inc.20035
*K984261Surestep Blood Glucose Monitoring System
Summary page 2
…bstantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential…
Lifescan, Inc.1999—
*K021513Accu-Chek Advantage Module
Summary page 2
…wing predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential Page 2…
Roche Diagnostics Corp.2002—

Also cleared against K024194: 14 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 14 other devices also cite its predicate K024194.

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 G4TM Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm. The G4TM Test Strips is used for the quantitative measurement of glucose…

Read the full statement (164 words)

The G4TM Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.

The G4TM Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.

The G4TM Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.

Indications for use as stated in the FDA summary.

Also cleared against K024194

14 other devices cite the same predicate.

  • K082683SD Check GoldStandard Diagnostics, Inc. · 2009
  • K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
  • K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color)I-Sens, Inc. · 2009
  • K080923Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA…I-Sens, Inc. · 2008
  • K073030AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
  • K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc. · 2007

More from U. S. Diagnostics, Inc.

22 FDA decisions under this applicant name. See the company

  • K110435Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc. · 2011
  • K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
  • K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc. · 2007
  • K870686Coagulation Control, Level IIU. S. Diagnostics, Inc. · 1987
  • K870687Coagulation Control, Level IiiU. S. Diagnostics, Inc. · 1987

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/K051651 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051651: G4, Model Igm-0004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051651

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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