# K964630: Glucometer Elite Blood Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Feb 10, 1997 after 83 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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.
23 later devices descend from it; 6 cite it directly.
0 of 24 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

## Most influential descendants
- K043311: Ascensia Elite Diabetes Care System (2004), 9 descendants of its own
- K040848: EZ Smart (2004), 8 descendants of its own
- K062538: Easy Check Blood Glucose Monitoring System (2007), 6 descendants of its own
- K052818: EZ Smart-168 Glucose Monitoring System (2006), 6 descendants of its own
- K090389: AP-1000 Blood Glucose Monitoring System (2009), 4 descendants of its own

## Indications for use
The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.*

Source page: https://510kreport.com/device/K964630
Methodology: https://510kreport.com/methodology