510(k) Report

510(k) · Cleared

Cleared

Arkray Diabetes Data Management Software (SMBG Viewer)

K093819510(k) TraditionalCleared Jun 9, 2010177-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

Arkray Factory USA, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jun 9, 2010 as substantially equivalent to K022545 (Hypoguard USA, Inc., 2002) after a 177-day review. Its family tree reaches back 2 generations to 2000.

Decided
Jun 9, 2010
Review
177 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K001907 (2000). No later device cites it as a predicate yet.

K001907 · Camit Diabetes Management Software · Roche Diagnostics Corp. · 2000K022545 · Glucobalance Data Management Software, Model 555020 · Hypoguard USA, Inc. · 20022000200220042006200820102012
K022545 · Glucobalance Data Management Software, Model 555020 · Hypoguard USA, Inc. · 2002K001907 · Camit Diabetes Management Software · Roche Diagnostics Corp. · 20000
  1. Root · 2 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
  2. 1 generation backK022545 Glucobalance Data Management Software, Model 555020Hypoguard USA, Inc. · 2002
  3. This deviceK093819 Arkray Diabetes Data Management Software (SMBG Viewer)Arkray Factory USA, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001907Camit Diabetes Management SoftwareRoche Diagnostics Corp.2000—
−1K022545Glucobalance Data Management Software, Model 555020Hypoguard USA, Inc.2002—
0 (this device)K093819Arkray Diabetes Data Management Software (SMBG Viewer)Arkray Factory USA, Inc.2010—
FIG. 1 — Lineage of K093819, 2000–2010Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K022545Glucobalance Data Management Software, Model 555020
Summary page 1
…Class 1I, and 21 CFR 862.2100, Class 1. Product Codes: OGA, NBW, JOP. Predicate Device: GlucoBalance Data Management Software (K022545). Device Description: The ARKRAY Diabetes Data Management Software is an optional accessory for use…
Hypoguard USA, Inc.2002—

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 10 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
  • None of the 2 ancestors has a recall.

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. 2010, 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 ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in…

Read the full statement (164 words)

The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

Indications for use as stated in the FDA summary.

More from Arkray Factory USA, Inc.

9 FDA decisions under this applicant name. See the company

  • K110709Ark Care Diabetes Managment SystemArkray Factory USA, Inc. · 2011
  • K092104Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc. · 2009
  • K091102Assure Platinum and Glucocard Vital Blood Glucose Monitoring SystemsArkray Factory USA, Inc. · 2009
  • K090653Pocketchem EZ Blood Glucose Monitoring SystemArkray Factory USA, Inc. · 2009
  • K090332Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc. · 2009

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/K093819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093819: Arkray Diabetes Data Management Software (SMBG Viewer).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093819

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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