# K120351: Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter Caresens N Blood Glucose Test Strip CA

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: May 3, 2012 after 87 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: 3 generations back to K024194 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color), I-Sens, Inc. (2009) Summary page 2.

## Indications for use
The CareSens N POP Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The CareSens N POP Blood Glucose Meter is intended for use with the CareSens N Sidgie Blood Glucose Test Strips for thc quantitative measurement of glucose in capillary whole blood from the fingertip and alternative sites such as the forearm, palm, thigh and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens Control Solutions are for use with the CareSens N POP Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly. The CareSens N POP Blood Glucose Monitoring System is intended for self testing, in vitro (outside the body) testing at home by people with diabetes as an aid in monitoring the effectiveness of a diabetes control program. 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/K120351
Methodology: https://510kreport.com/methodology