# K061118: Onetouch Ultramini Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: May 19, 2006 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.
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. The FDA summary names its predicate without a number.
- (no number) OneTouch Ultra Blood Glucose Monitoring System: named in the summary without a submission number

## Indications for use
The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Source page: https://510kreport.com/device/K061118
Methodology: https://510kreport.com/methodology