# K020208: Glucometer Elite Diabetes Care System (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Group Diagnostics
- Decided: Apr 29, 2002 after 97 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
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GLUCOMETER ELITE® Blood Glucose Meter: named in the summary without a submission number
- (no number) GLUCOMETER ELITE® XL Blood Glucose Meter: named in the summary without a submission number
- (no number) GLUCOMTER ELITE® Test Strips: named in the summary without a submission number

## Most influential descendants
- K043311: Ascensia Elite Diabetes Care System (2004), 9 descendants of its own
- K062538: Easy Check Blood Glucose Monitoring System (2007), 6 descendants of its own
- K042795: Clever Chek TD-3213 (2005), 6 descendants of its own
- K090389: AP-1000 Blood Glucose Monitoring System (2009), 4 descendants of its own
- K062800: Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose Plus Blo (2007), 2 descendants of its own

## Indications for use
The GLUCOMETER ELITE® and the GLUCOMETER ELITE® XL Blood Glucose Meters are used with GLUCOMETER ELITE® Test Strips to measure glucose levels in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The GLUCOMETER ELITE Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K020208
Methodology: https://510kreport.com/methodology