# K053529: Onetouch Ultra 2 Blood Glucose Monitoring System - Pathway: 510(k) (Special) - Applicant: Lifescan, Inc. - Decided: Jan 17, 2006 after 29 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. 34 later devices descend from it; 6 cite it directly. 0 of 35 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The summary cites one number, which could not be confirmed as its predicate (listed below). ## Cited in the summary but kept off the family tree - K012197: Powerheart Cardiac Rhythm Module, Cardiac Science, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K073231: Onetouch Ultralink Blood Glucose Monitoring System (2008), 15 descendants of its own - K110894: Contour Next Link Wireless Blood Glucose Meter (2012), 13 descendants of its own - K121087: Contour Next Usb Blood Glucose Monitoring System (2012), 10 descendants of its own - K150942: Contour Next USB Blood Glucose Monitoring System (2015), 9 descendants of its own - K093745: One Touch Verio Blood Glucose Monitoring System (2011), 9 descendants of its own ## Indications for use The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 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 Ultra 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm. Source page: https://510kreport.com/device/K053529 Methodology: https://510kreport.com/methodology