510(k) Report

510(k) · Cleared

Cleared

Gluco Track Blood Glucose Monitoring System

K062799510(k) TraditionalCleared Feb 6, 2007140-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. · CGA Glucose Oxidase, Glucose

Cleared on Feb 6, 2007 as substantially equivalent to K011233 (Apex BioTechnology Corp., 2001) after a 140-day review. Its family tree reaches back 1 generation to 2001. 18 later devices descend from it.

Decided
Feb 6, 2007
Review
140 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011233 (2001). 18 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2008: 2 descendants cleared2012: 3 descendants cleared2014: 2 descendants cleared2022: 3 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant clearedK011233 · Modification to Glucosure BGM System, Model 221100 · Apex BioTechnology Corp. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K011233 · Modification to Glucosure BGM System, Model 221100 · Apex BioTechnology Corp. · 2001 · recalled0+5
  1. Root · 1 generation backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
  2. This deviceK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
  3. Descendant · cites it directly · 13 of its ownK073648 Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008
  4. Descendant · 2 generations on · 12 of its ownK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
  5. Descendant · 3 generations on · 9 of its ownK113208 Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012
  6. Descendant · 4 generations on · 3 of its ownK141036 BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015
  7. Descendant · 4 generations on · 3 of its ownK131750 Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2008: 22011: 22012: 32014: 22015: 22016: 12017: 12018: 12021: 12022: 3
2008high 3 (2012) · low 0 (2009)2026

Most influential descendants

Showing 5 of 18 · See all
  • K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008 · cites it directly13descendants
  • K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011 · 2 generations on12descendants
  • K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012 · 3 generations on9descendants
  • K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · 4 generations on3descendants
  • K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2014 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011233Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp.20011
0 (this device)K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp.2007—
+1K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp.2008—
+2K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp.2011—
+3K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp.2012—
+4K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.2015—
+4K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201120
201230
201420
201520
201610
201710
201810
202110
202230
FIG. 1 — Lineage of K062799, 2001–2022Source: 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 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
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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
*K011233Modification to Glucosure BGM System, Model 221100
Summary page 1
…tiveness Information * Predicate Device: Claim of Substantial Equivalence (SE) is made to GlucoSure® Blood Glucose Monitoring System (K011233) * Device Description: Based on an electrochemical biosensor technology and the principle of capilla…
Apex BioTechnology Corp.20011

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp.200813
K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc.20112
K073137Glucosure Voice Blood Glucose Monitoring System, Model AS90011E1Apex BioTechnology Corp.20080

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 a recall.
  • Of its descendants, K073648 (Apex BioTechnology Corp., 2008) has gone furthest, with 13 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. 2007, this device’s year, is highlighted.

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 Gluco Track Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary, fingerstick whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for both lay use by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus.

Indications for use as stated in the FDA summary.

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
  • K212140GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2022
  • K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2022

Recent decisions in CGA

The CGA category page

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https://510kreport.com/device/K062799 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062799: Gluco Track Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062799

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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