510(k) Report

510(k) · Cleared

Cleared

GlucoSure Link Blood Glucose Monitoring System

K212140510(k) TraditionalCleared Aug 25, 2022413-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

Apex BioTechnology Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Aug 25, 2022 as substantially equivalent to K102037 (Apex BioTechnology Corp., 2010) after a 413-day review. Its family tree reaches back 1 generation to 2010.

Decided
Aug 25, 2022
Review
413 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K102037 (2010). No later device cites it as a predicate yet.

Reference device: K150396 · Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips · Apex BioTechnology Corp. · 2015K102037 · Autosure Voice II Blood Glucose Monitoring System and Test Strips · Apex BioTechnology Corp. · 201020102012201420162018202020222024
K102037 · Autosure Voice II Blood Glucose Monitoring System and Test Strips · Apex BioTechnology Corp. · 20100
  1. Root · 1 generation backK102037 Autosure Voice II Blood Glucose Monitoring System and Test StripsApex BioTechnology Corp. · 2010
  2. This deviceK212140 GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K102037Autosure Voice II Blood Glucose Monitoring System and Test StripsApex BioTechnology Corp.2010—
0 (this device)K212140GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp.2022—
FIG. 1 — Lineage of K212140, 2010–2022Source: 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
*K102037Autosure Voice II Blood Glucose Monitoring System and Test Strips
Summary page 4
…System Classification: Glucose test system, 21 CFR 862.1345, Class II Product Codes: NBW Predicate Devices: AutoSure Voice II Blood Glucose System (k102037) Device Description: The GlucoSure Link blood glucose monitoring system consists of the GlucoSure Link…
Apex BioTechnology Corp.2010—
†K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose…Apex BioTechnology Corp.2015—

Also cleared against K102037: 3 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?

  • Its one ancestor has no recall.
  • 3 other devices also cite its predicate K102037.

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. 2022, 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 GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips. The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This…

Read the full statement (128 words)

The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips.

The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

Indications for use as stated in the FDA summary.

Also cleared against K102037

3 other devices cite the same predicate.

  • K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System…Apex BioTechnology Corp. · 2015
  • K113098Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus IiiApex BioTechnology Corp. · 2012
  • K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use…Telcare, Inc. · 20111 recall

More from Apex BioTechnology Corp.

35 FDA decisions under this applicant name. See the company

  • K242209UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp. · 2025
  • K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
  • K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
  • K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2022
  • K213887GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022

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/K212140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212140: GlucoSure Link 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/K212140

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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