# K073231: Onetouch Ultralink Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Apr 18, 2008 after 155 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
Longest line of descent: 2 generations back to K030531 (2003). 3 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System, Lifescan, Inc. (2006) Summary page 1.
- K040603: Paradigm Link Blood Glucose Meter, Becton, Dickinson & CO (2004) Summary page 1.

## Most influential descendants
- 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
- K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System (2016), 8 descendants of its own
- K193407: Contour® next GEN Blood Glucose Monitoring System (2021), 5 descendants of its own

## Indications for use
The OneTouch UltraLink TM Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink TM System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® UltraLinkTM Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

Source page: https://510kreport.com/device/K073231
Methodology: https://510kreport.com/methodology