# K081318: Onetouch Zoom Diabetes Management Program

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Jun 9, 2008 after 28 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.
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. The FDA summary names its predicate without a number.
- (no number) OneTouch® Diabetes Management Software: named in the summary without a submission number

## Most influential descendants
- K103643: Ascot Home Medical Monitoring System (HMMS) (2011), 0 descendants of its own

## Indications for use
The ONE TOUCH® ZoomTM Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan blood glucose monitoring systems with data management capabilities.

Source page: https://510kreport.com/device/K081318
Methodology: https://510kreport.com/methodology