510(k) · Cleared
ClearedGal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi Blood Glucose Monitoring System Gal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · CGA Glucose Oxidase, Glucose
Cleared on Mar 28, 2012 as substantially equivalent to K102816 (Apex BioTechnology Corp., 2011) after a 118-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Mar 28, 2012
- Review
- 118 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011233 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
- 3 generations backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
- 2 generations backK073648 Glucosure Star Blood Glucose Monitoring System, Model AS90000E1Apex BioTechnology Corp. · 2008
- 1 generation backK102816 Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsApex BioTechnology Corp. · 2011
- This deviceK113547 Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test…Apex BioTechnology Corp. · 2012
- Descendant · cites it directly · 0 of its ownK142689 GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose…Apex BioTechnology Corp. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011233 | Modification to Glucosure BGM System, Model 221100 | Apex BioTechnology Corp. | 2001 | 1 |
| −3 | K062799 | Gluco Track Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2007 | — |
| −2 | K073648 | Glucosure Star Blood Glucose Monitoring System, Model AS90000E1 | Apex BioTechnology Corp. | 2008 | — |
| −1 | K102816 | Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips | Apex BioTechnology Corp. | 2011 | — |
| 0 (this device) | K113547 | Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E… | Apex BioTechnology Corp. | 2012 | — |
| +1 | K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring… | Apex BioTechnology Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102816 | Gal-1C Blood Glucose Monitoring System, Gal-1C Test StripsSummary page 1…Strips Classification: Glucose test system, 21 CFR 862.1345, Class 1I Product Codes: CGA, NBW Predicate Device: GAL-IC Blood Glucose Monitoring System (k102816) GAL-IC Blood Glucose Test Strip (k102816) Device Description: The GAL-IE blood glucose meter and GAL-iF… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | 2015 | 0 |
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?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K142689 (Apex BioTechnology Corp., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102816.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GAL-IE 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.rstate (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus…
Read the full statement (352 words)
The GAL-IE 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.rstate (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-IE Blood Glucose Test Strips are to be used with the GAL'IE Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-lE Multi 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). Testing is done outside the body (In Vitro diagnostic use). It is indicated to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-lE Multi Blood Glucose Test Strips are to be used with the GAL-IE3 Multi Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use. They are indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113547: Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi Blood Glucose Monitoring System Gal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113547
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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