# K944459: Accu-Chek Instant Plus G-C/DM Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Apr 17, 1996 after 583 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Accu-Chek® Easy™ System: named in the summary without a submission number
- (no number) Accu-Chek Easy Self Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K051376: Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose (2005), 0 descendants of its own
- K991075: Atlast Glucose Control Solution (1999), 0 descendants of its own

## Indications for use
For use by professionals and people with diabetes for the quantitative determination of glucose in whole blood.

Source page: https://510kreport.com/device/K944459
Methodology: https://510kreport.com/methodology