510(k) Report

510(k) · Cleared

Cleared

Assure Pro Blood Glucose Monitoring System, Model 46001

K090332510(k) TraditionalCleared Aug 14, 2009185-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 Aug 14, 2009 as substantially equivalent to K053079 (Hypoguard USA, Inc., 2006) after a 185-day review. Its family tree reaches back 1 generation to 2006.

Decided
Aug 14, 2009
Review
185 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K053079 (2006). No later device cites it as a predicate yet.

K053079 · Assure Pro Blood Glucose Monitoring System, Model 460001 · Hypoguard USA, Inc. · 2006200620082010
K053079 · Assure Pro Blood Glucose Monitoring System, Model 460001 · Hypoguard USA, Inc. · 20060
  1. Root · 1 generation backK053079 Assure Pro Blood Glucose Monitoring System, Model 460001Hypoguard USA, Inc. · 2006
  2. This deviceK090332 Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K053079Assure Pro Blood Glucose Monitoring System, Model 460001Hypoguard USA, Inc.2006—
0 (this device)K090332Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc.2009—
FIG. 1 — Lineage of K090332, 2006–2009Source: 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
*K053079Assure Pro Blood Glucose Monitoring System, Model 460001
Summary page 1
…lassification: Glucose test system, 21 CFR 862.1345 and 862.1660; Class II Product Codes: CGA, NBW, JJX Predicate Device: Assure Pro Meter (K053079) Device Description: The Assure Pro Blood Glucose Monitoring System consists of a meter, test str…
Hypoguard USA, Inc.2006—

Also cleared against K053079: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K053079.

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. 2009, 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?

Assure Pro Blood Glucose Monitoring System: The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinicar settings by healthcare professionals, as an aid to monitor the effectiveness of…

Read the full statement (296 words)

Assure Pro Blood Glucose Monitoring System:

The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinicar settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The Assure Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Assure Pro Blood Glucose Meter:

The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure Pro Blood Glucose Test Strips:

Assure Pro test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure Dose CONTROL:

For use with Assure Pro Blood Glucose Meter and Assure Pro Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Level 1 (Normal) and Level 2(High).

Indications for use as stated in the FDA summary.

Also cleared against K053079

1 other device cites the same predicate.

  • K092104Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc. · 2009

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
  • K093819Arkray Diabetes Data Management Software (SMBG Viewer)Arkray Factory USA, Inc. · 2010
  • 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

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/K090332 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090332: Assure Pro Blood Glucose Monitoring System, Model 46001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090332

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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