510(k) Report

510(k) · Cleared

Cleared

Assure Pro Blood Glucose Monitoring System, Model 460001

K053079510(k) TraditionalCleared Mar 28, 2006146-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

Hypoguard USA, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Mar 28, 2006 after a 146-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
Mar 28, 2006
Review
146 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared20052010201520202025
  1. This deviceK053079 Assure Pro Blood Glucose Monitoring System, Model 460001Hypoguard USA, Inc. · 2006
  2. Descendant · cites it directly · 0 of its ownK092104 Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc. · 2009
  3. Descendant · cites it directly · 0 of its ownK090332 Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K092104Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc. · 2009 · cites it directly0descendants
  • K090332Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K053079Assure Pro Blood Glucose Monitoring System, Model 460001Hypoguard USA, Inc.2006—
+1K092104Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc.2009—
+1K090332Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
FIG. 1 — Lineage of K053079, 2006–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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
*—Assure Pro Blood Glucose Monitoring System
Named without a submission number
—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K092104Assure Platinum Blood Glucose Monitoring SystemArkray Factory USA, Inc.20090
K090332Assure Pro Blood Glucose Monitoring System, Model 46001Arkray Factory USA, Inc.20090

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?

  • Of its descendants, K092104 (Arkray Factory USA, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

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

Read the full statement (218 words)

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

The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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 Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are 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.

For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Indications for use as stated in the FDA summary.

More from Hypoguard USA, Inc.

9 FDA decisions under this applicant name. See the company

  • K051514Assure Pro Blood Glucose Monitoring System, Model 460002Hypoguard USA, Inc. · 2005
  • K041881Advance Micro-Draw Blood Glucose Monitoring System, Model 411100Hypoguard USA, Inc. · 2005
  • K033851Diascreen Reagent Strips for Urinalysis, Models D122OO (2GK), D12100 (1K), D11100 (1G)Hypoguard USA, Inc. · 2004
  • K031388Modification to Hypoguard Advance Blood Glucose Monitoring SystemHypoguard USA, Inc. · 2003
  • K024347Express Blood Glucose Monitoring SystemHypoguard USA, Inc. · 2003

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https://510kreport.com/device/K053079 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053079: Assure Pro Blood Glucose Monitoring System, Model 460001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053079

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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