# K951537: Glucometer Elite M Blood Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 14, 1995 after 102 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K991480: Excel GE Blood Glucose Test Strips & Code Strip (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K951537
Methodology: https://510kreport.com/methodology