510(k) Report

510(k) · Cleared

Recalled · 2007

Modification to Glucosure BGM System, Model 221100

K011233510(k) SpecialCleared May 18, 200125-day reviewClass II21 CFR 862.1345Recalls 1

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 May 18, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled once.

Decided
May 18, 2001
Review
25 days
Class
Class II
Product code
CGA
Recalls
1
Predicates
0

19 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2011: 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 cleared200020052010201520202025
  1. This deviceK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001
  2. Descendant · cites it directly · 18 of its ownK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
  3. Descendant · 2 generations on · 13 of its ownK073648 Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008
  4. Descendant · 3 generations on · 12 of its ownK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
  5. Descendant · 4 generations on · 9 of its ownK113208 Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012
  6. Descendant · 5 generations on · 3 of its ownK141036 BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22011: 22012: 32014: 22015: 22016: 12017: 12018: 12021: 12022: 3
2007high 3 (2012) · low 0 (2009)2026

Most influential descendants

Showing 5 of 19 · See all
  • K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007 · cites it directly18descendants
  • K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008 · 2 generations on13descendants
  • K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011 · 3 generations on12descendants
  • K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2012 · 4 generations on9descendants
  • K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011233Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp.2001—
+1K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp.2007—
+2K073648Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp.2008—
+3K102816Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp.2011—
+4K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp.2012—
+5K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201120
201230
201420
201520
201610
201710
201810
202110
202230
FIG. 1 — Lineage of K011233, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062799Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp.200718

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 16, 2007Not classifiedZ-0699-2008Process designMislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062799 (Apex BioTechnology Corp., 2007) has gone furthest, with 18 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—

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35 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K011233 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011233: Modification to Glucosure BGM System, Model 221100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011233

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026