# K193475: OneTouch Verio Reflect Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan Europe GmbH
- Decided: Feb 14, 2020 after 60 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: 5 generations back to K053529 (2006). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150214: OneTouch Verio Flex Blood Glucose Monitoring System, Lifescan Europe (2015) Summary page 5.

## Most influential descendants
- K240640: Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (2024), 0 descendants of its own

## Indications for use
The OneTouch Verio Reflect Blood Glucose Monitoring System is composed of the OneTouch Verio Reflect Meter and OneTouch Verio Test Strips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

Source page: https://510kreport.com/device/K193475
Methodology: https://510kreport.com/methodology