510(k) Report

510(k) · Cleared

Cleared

Easygluco Plus Blood Glucose Monitoring System

K110435510(k) SpecialCleared Sep 21, 2011218-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 Sep 21, 2011 as substantially equivalent to K082201 (U. S. Diagnostics, Inc., 2009) after a 218-day review. Its family tree reaches back 3 generations to 1995.

Decided
Sep 21, 2011
Review
218 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K942455 (1995). 6 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. · 1999K082201 · G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A · U. S. Diagnostics, Inc. · 20091995200020052010
Other ancestors, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor K082201 · G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A · U. S. Diagnostics, Inc. · 2009K984261 · Surestep Blood Glucose Monitoring System · Lifescan, Inc. · 1999K942455 · Lifescan Surestep Blood Glucose Monitoring System · Lifescan, Inc. · 19950
  1. Root · 3 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
  2. 2 generations backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
  3. 1 generation backK082201 G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
  4. This deviceK110435 Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K942455Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc.1995—
−2K984261Surestep Blood Glucose Monitoring SystemLifescan, Inc.1999—
−1K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc.2009—
0 (this device)K110435Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
FIG. 1 — Lineage of K110435, 1995–2011Source: 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
*K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A
Summary page 1
…ring System Predicate Device: We claim substantial equivalence to the G5 Infinity Blood Glucose Monitoring System, K082201. Device Description: The EasyGluco® Plus Monitor is an in vitro diagnostic device designed fo…
U. S. Diagnostics, Inc.2009—

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 16 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
  • 2 of the 6 ancestors have a recall of any class.

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. 2011, 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 EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not…

Read the full statement (191 words)

The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person.

EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The EasyGluco® Plus Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The EasyGluco® Plus Blood Glucose Test Strips are for use with the EasyGluco® Plus Blood Glucose Monitor for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from U. S. Diagnostics, Inc.

22 FDA decisions under this applicant name. See the company

  • K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
  • K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc. · 2007
  • K051651G4, Model Igm-0004U. S. Diagnostics, Inc. · 2006
  • 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/K110435 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110435: Easygluco Plus 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/K110435

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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