# K021819: One Touch Ultrasmart Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Aug 23, 2002 after 80 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
Longest line of descent: 1 generation back to K950727 (1995). 2 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002134: One Touch Ultra Blood Glucose Monitoring System, Selfcare, Inc. (2000)
- K950727: One Touch Profile Complete Diabetes Tracking System, Lifescan, Inc. (1995) Summary page 1.

## Most influential descendants
- K072369: Evolution Blood Glucose Monitoring System (2008), 21 descendants of its own
- K081703: Myglucohealth Glucose Monitoring Systems (2009), 10 descendants of its own
- K113105: Tempusic Patient Monitor (2011), 8 descendants of its own
- K152124: Tempus IC2 (2015), 7 descendants of its own
- K152645: Dictum Health (2016), 6 descendants of its own

## Recalls of this device
- Jun 9, 2005 · Not classified · Z-0980-05: Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas th

## Indications for use
The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart™ System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The One Touch® UltraSmart™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.

Source page: https://510kreport.com/device/K021819
Methodology: https://510kreport.com/methodology