# K201394: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Oct 5, 2021 after 496 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CareSens N Feliz BT Blood Glucose Monitoring System is comprised of the CareSens N Blood Glucose Test Strips and the CareSens N Feliz BT Blood Glucose Meter. The CareSens N Feliz BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Feliz BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Source page: https://510kreport.com/device/K201394
Methodology: https://510kreport.com/methodology