# K131469: Acon on Call Diabetes Management Software

- Pathway: 510(k) (Special)
- Applicant: ACON Laboratories, Inc.
- Decided: Jan 6, 2014 after 230 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Pius glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On7CalI Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Source page: https://510kreport.com/device/K131469
Methodology: https://510kreport.com/methodology