# K011233: Modification to Glucosure BGM System, Model 221100

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: May 18, 2001 after 25 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062799: Gluco Track Blood Glucose Monitoring System (2007), 18 descendants of its own
- K073648: Glucosure Star Blood Glucose Monitoring System, Model AS90000E1 (2008), 13 descendants of its own
- K102816: Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips (2011), 12 descendants of its own
- K113208: Gal-1A Blood Glucose Monitoring System (2012), 9 descendants of its own
- K141036: BGM009 Blood Glucose Monitoring System (2015), 3 descendants of its own

## Recalls of this device
- Nov 16, 2007 · Not classified · Z-0699-2008: Mislabeling: 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.

Source page: https://510kreport.com/device/K011233
Methodology: https://510kreport.com/methodology