# K052469: Glucopack

- Pathway: 510(k) (Traditional)
- Applicant: Healthpia America Corp.
- Decided: Jun 5, 2006 after 270 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942455 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 2.
- K984261: Surestep Blood Glucose Monitoring System, Lifescan, Inc. (1999) Summary page 2.
- K021513: Accu-Chek Advantage Module, Roche Diagnostics Corp. (2002) Summary page 2.
- (no number) EasyGluco™: named in the summary without a submission number

## Most influential descendants
- K091168: Glucophone Blood Glucose Test System, Model Igm-0025 (2010), 0 descendants of its own

## Indications for use
The GlucoPack Diabetes Monitoring' System is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.

Source page: https://510kreport.com/device/K052469
Methodology: https://510kreport.com/methodology