# K072543: Onetouch Select Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Oct 5, 2007 after 25 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 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 Ultra 2 Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K093745: One Touch Verio Blood Glucose Monitoring System (2011), 9 descendants of its own
- K110637: Onetouch Verio (TM) IQ Blood Glucose Monitoring System (2011), 7 descendants of its own
- K131363: Onetouch Verio Blood Glucose Monitoring System (2013), 6 descendants of its own
- K150214: OneTouch Verio Flex Blood Glucose Monitoring System (2015), 4 descendants of its own
- K193475: OneTouch Verio Reflect Blood Glucose Monitoring System (2020), 1 descendant of its own

## Recalls of this device
- Feb 25, 2013 · Class II · Z-1130-2013: When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial

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

Source page: https://510kreport.com/device/K072543
Methodology: https://510kreport.com/methodology